Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Global post market surveillance data showed two (2) reports from 2016 and 2017 concerning in situ inlay breakage of balansys uni convex pe inlays x/6 after approximately eight years. in 2015 mathys ltd bettlach made the decision to phase-out the balansys uni convex unicompartmental knee system based on economic grounds, with only the uni convex pe inlays to be retained to allow for potential minor revision surgeries. the phase out was initiated in december 2015, and completed by december 2016. in november 2016, a field safety corrective action was carried out to recall all balansys uni convex pe inlays x/5 (thickness 5 mm) from the market after the occurrence of seven (7) breakages of the inlays x/5. no events have been reported for x/7 and x/9.
Action
Mathys Orthopaedics is advising surgeons to inform affected patients implanted with a size x/6, x/7 and x/9 inlay about the risks of PE inlay breakage and any further associated potential risks while maintaining their routine follow-up protocol. The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of each patients’ clinical circumstances.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
While creating or modifying a report using microsoft word application in classic client, when content is pasted form an external source including the formatting 'section break' or by inserting it manually, data from the pre-defined sections of the template might not be saved to the syngo workflow mlr database. this incomplete report from the database issued for distribution to external systems e.G. his, pacs or fax. in the classic client report viewer the content is complete.To date, no harm has been reported as a result of this issue.
Action
Siemens is preparing a correction to rectify this issue. In the interim, users are advised to always use the standard report creating options of syngo Workflow MLR Classic Client:
1. Use the online speech recognition to dictate the report with the supplied microphone.
2. Type content in the report editor.
3. Use auto text module to speed up the reporting process.
4. Only copy/paste from ASCII view of prior reports in syngo Workflow MLR Classic Client.
In the case that users cannot avoid copy and pasting within the same document or from external applications, on all syngo Workflow MLR workstations the default paste option of the Microsoft Word application shall be set to 'KeepTextOnly'. Users may refer to the Customer Letter for further instructions regarding this.
In the event that a report was created using copy and paste, users should always verify the content for completeness. Instructions for this are provided in the Customer Letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Aquios cl system will associate the wrong sample id with results in the event the following sequence occurs: -the stat button is selected within aquios cl software and the user opens the single-tube loader door. - user creates a test request when prompted, places a specimen tube in single tube loader, and closes the single-tube loader door. - the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the “details” column on running screen changes to “prepping” for that sample. - user removes the first specimen tube and replaces with a different specimen tube. this issue was discovered internally during a verification test. there have been no reported similar events from the field.
Action
Beckman Coulter has released the software correction for this issue at the end of January 2018. A Beckman Coulter Field Service Engineer will contact users to schedule the installation of the software upgrade.
In the interim, users are advised to follow the steps and warnings outlines in the IFU when running STAT specimens to avoid sample mis-identification.
When running multiple specimen via the single tube loader, wait for the currently loaded specimen to be in the "incubating" status in the "details" column on the Running screen before selecting the STAT button or attempting to cancel the run.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Stryker has discovered that certain ethernet to fibre optic converters did not pass testing due to a rio connection error. a rio connection error will occur when communication is lost between the rio and the guidance module. in the event a mako system experiences a rio connection error, a network connection error message will appear on the system display.
Action
Stryker will arrange replacement of all Ethernet to Fibre Optic Converters of affected units with updated converters.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
A malfunction of elia anti-tsh-r well carriers 14-5639-01 in lot 0014 has been discovered. the specified lot includes a limited number of carriers, where 8 or 16 wells in sequence will produce decreased response units (ru). out of 4122 carriers, to date 12 carriers have been identified giving this low ru pattern.To date, no adverse events have been reported. in australia these kits are currently used for evaluation purposes, not for generating patient results.This recall does not affect any other lots of elia anti-tsh-r or any other phadia products.
Action
Abacus ALS is advising affected users to quarantine any affected stock of the specified lot and discontinue use.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
3m recently became aware that a design change to the bair hugger full access underbody blanket, models 63500, can make them more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. the health risk associated with this issue is if blankets are only partially inflated during use in surgery, it could result in incomplete warming therapy. loss of therapy may lead to in advert perioperative hypothermia. this recall does not affect any other lots of 3m bair hugger full access underbody blanket.
Action
3M is advising users to inspect inventory and quarantine affected stock of the specified lot numbers immediately to prevent further use. 3M will be in contact with users to arrange collection of affected stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Medline has been made aware of overseas complaints from users regarding swivelling of the suction tip of the handle of these devices. depending on the type of procedure, there is a potential for serious harm such as delayed recovery/delay in treatment, and tissue damage. it is very likely that the user may still be able to continue suctioning even after the suction tip starts to swivel within the handle. the chances of detecting the swivel by the user remain high.No complaints for this issue have been received to date in australia. no patient harm has been reported as a result of this issue.
Action
Medline is advising users to inspect the Frazier suction handle for a loose tip prior to use. Additional/alternative Frazier units may be kept on standby just in case users experience swivelling of the suction tip.
The manufacturer is currently validating a revised manufacturing process after shifting the bending fulcrum of the bending fixture from the handle to the metal tube thus reducing the impact of the bending force on the handle. After successful validation and product testing, the revised product will be introduced to the market.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer has become aware of the potential for loose brake pedal screws (part number s1306) which are responsible for connecting the brake pedal with the base frame of the bed and keeping the brake in the correct position. this issue of loose screws is visible to users. there is no evidence to suggest that this anomaly is related with any potential risk to users.
Action
Arjo is advising users to inspect the beds to determine if the screws are loose on the brake mechanism.
If users see that the screw is not tightened fully, it means thatthe device is affected by this correction.
Check the castor operation, paying attention to steering and/or braking function. If users detect small movements between the parts and loose movement between braking system, it means the device may be affected by this correction.
Arjo will be inspecting the affected devices and replacing the affected screws during the next service visit.
Users that undertake serving of their own devices are advised to unscrew the old screw S1306 and replace with new one, by use the torque wrench with 10.2 Nm torque.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens healthcare diagnostics has confirmed that the affected dimension vista calcium (ca) flex reagent cartridge may produce erroneously low results from specific well sets. quality control (qc) may not detect the issue prior to patient testing if the ca calibration and qc are both processed in either an affected or unaffected well set.If ca reagent calibration is performed using an unaffected well set and qc and samples are subsequently processed using an affected well set, ca results may be falsely depressed, with observed biases from -0.075 mmol/l] to -0.7 mmol/l. if a ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated. the observed bias for serum, plasma, and urine specimens are similar.
Action
Siemens Healthcare is advising users to discontinue use of, and discard the Dimension Vista Calcium Flex reagent lot 17171BD.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer, ibl has detected an issue that indicates a degradation in performance of the kit resulting in elevated cortisol values. when testing patient samples with one of the affected lots, the controls and calibrator values will meet specifications; however, due to a degradation in the starting concentration of the calibration standards, the calculated results for individual patient samples may be higher compared to lc-ms/ms measurements and may trigger unnecessary additional testing.A review of additional data comparing the respective kit standards of the lots to lc-ms/ms data it is evident that the lots eco142 to eco143 generate elevated results:- eco142 (passing bablok fit (y=0.009988 + 1.549x)- eco143 (passing bablok fit (y=0.003142 + 1.623x)there has not been any reports of injuries associated with this issue.
Action
Abacus is advising users to inspect stock and quarantine any remaining stock of the affected batches. Affected product will be replaced with unaffected stock.
A review of previously generated patient results is at the discretion of the Laboratory Director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Device technologies australia (dta) in conjunction with the manufacturer, carefusion germany 234 gmbh, have been made aware of an issue regarding the tubing for option diffusion at the vyntus body the medicinal gas mixture (i.E. promed pul-p) can flood inside the cabin, if: - the gas bottle is not regularly closed after finishing the diffusion measurement; and- the tubing inside the cabin has a significant leakage (audible fizzle).The inhalation of large quantities of gas mixture can result in dizziness and headache if the whole content of the gas bottle is emptied into the closed cabin. there have been no reports of injuries associated with this issue.
Action
A representative from DTA will be in contact with affected users to arrange onsite correction of the devices. The tubing including the demand valve will be exchanged.
In the interim, DTA is advising users to perform a diffusion measurement with wide opened cabin door or outside the cabin. After finishing the diffusion measurement or during all other measurements, ensure the gas bottle valve is closed properly as noted in the IFU. Users should also ensure there is sufficient ventilation in the room as noted in the IFU.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens has been notified by the manufacturer that a mismatch has been identified between orientation labels and displayed anatomy (e.G. in the 3d task card) within the software version syngo e11p. this will lead to wrong attenuation correction of the pet data.The issue occurs when changing the image numbering in transversal mrac protocol (e.G. mrac_caipi_hires protocol) from the default setting "feet>>head" to a customised setting "head>>feet". the original images are labelled correctly, but the composed images are flipped by 180 degrees and shifted.There have been no injuries reported as a result of this issue.
Action
Siemens is advising that this issue will be corrected in the next service pack syngoE11P-SP03. In the interim, do not change the numbering of images in transversal MRAC protocols (within an MRPET workflow). Follow the user manual. Don't rely only on composed images; always additionally refer to the original images for diagnostic purposes.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The tristel trio wipes system has been validated for efficacy and residual toxicity for tee probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans. further testing has identified a need for clarification of the previously communicated disinfection guidance for ge tee probes regarding use of the tristel trio wipes system. specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods using tristel trio wipes may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. ge recommends the additional use of a sterile sheath covering the tee probe when tristel trio wipes are being used as the sole method of disinfection.
Action
Under conditions where the TEE probe has a long intubation time or shows visible signs of wear and damage, GE recommends the use of a sterile sheath covering the TEE probe in addition to disinfection using the Tristel Trio Wipes System.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The 3d esie pisa volume analysis application quantifies valvular regurgitation. while imaging with the z6ms volume transesophageal echocardiography transducer, this application may underestimate the eroa (effective regurgitant orifice area) in comparison to the same patient results obtained with the 4z1c volume transthoracic echocardiography transducer.There is a low risk of misdiagnosis occurring from underestimating the patient's mitral regurgitation severity when using the esie pisa analysis application with the z6ms volume transesophageal echocardiography transducer.
Action
Siemens is advising that users should continue to rely on a combination of several quantitative parameters for evaluation of mitral regurgitation rather than solely on the EROA derived from eSie PISA analysis with the Z6Ms transducer.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer is aware that there is natural rubber latex (1%) in the futuro quick strap ankle support. currently packaging of this product does not have an explicit caution statement in relation to latex.The existing caution statement available on this product is "caution: some individuals may be sensitive to neoprene or neoprene blend rubber. if a rash develops, discontinue use and consult a physician".Individuals that are sensitive to latex may develop an allergic reaction.No alleged medical complaints regarding this product have been received in australia during its period of distribution.This recall does not affect any other 3m products.
Action
3M is advising pharmacies to quarantine affected stock and return it to the distributor.
3M will arrange collection of affected devices from distributors.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Cook medical has become aware that an incorrect patient card may have been included in the zenith branch endovascular graft - iliac bifurcation (zbis) devices supplied between november 2017 and january 2018. the device name on the incorrect patient card is zenith p-branch and the mri image artefact radius specified on the zbis patient card is slightly different from the image artefact radius on the incorrect patient card. the patient card is the only portion of the product impacted, there is no impact on the packaged device.There have been no customer complaints received to date in regards to this issue.
Action
Cook Medical is providing replacement patient cards to all affected customers.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens healthineers has become aware of an issue with the pet quality control software that introduces an error into the pet normalization file. as a result there may be minimal visual and quantitative impacts to the pet images acquired and reconstructed with petsyngo vj20a software.
Action
Siemens will be in contact with affected customers to arrange for a software update to be installed.
In the event that users have any concerns about data that has been previously acquired and reconstructed prior to correction, users may refer to the Customer Letter for instructions for reconstructing data with a new normalization file.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer, getinge, has received complaints concerning unintentional drifting of the cupola during surgery due to prematurely worn out brake screws. the observed movement is a slow rotation of the cupola around the axis, potentially shifting the light patch away from the wound.Clinical evaluations concluded that there is a low risk of injury or other health consequences expected for the patient or the user. only one (i.E. the heavier) cupola of a configuration is concerned by the malfunction, and the second cupola provides sufficient illumination of the surgical area if the issue occurs during surgery.
Action
Getinge is advising users that a service technician will be correcting all affected units.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer, southwest technologies are recalling all hypothermia products including caps, mittens and slippers for the intended use of reduction of chemotherpay induced alopecia, onycholysis and skin toxicity. the devices are misbranded for use during chemotherapy treatments, and may lead to frostbite to digits on patients with, but not limited to diabetic neuropathy, raynaud's disease, distal metastasis, distal arteriopathy and cold intolerance. there have been reports of serious injuries overseas as a result of this issue.
Action
Control Medics is advising customers to discontinue use of affected products immediately. Customers are advised to quarantine all affected stock to prevent further use and return it to Control Medics.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Arjo has received a limited number of complaints where it was noted there was a disconnection of the spreader bar from the quick connect scale.This occurence may result in users falling whilst the device is in use.
Action
Arjo will be in contact with affected users to arrange for devices to be upgraded
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Braun has been notified by the manufacturer that an error in the initial manufacture of these items has been identified resulting in a potential for the protective sleeves to become “sticky” after reprocessing.It has been determined that the used plastic sleeves of the instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing.
Action
B Braun is advising users to ensure that the affected products are no longer used and to complete and fax the Facsimile Reply Form provided with the Customer Letter to them so that they may arrange for devices to be collected and repaired.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Life technologies has become aware of a performance issue where the specific lots of foetal haemoglobin monoclonal antibody are displaying high or unusually bright background which could potentially lead to erroneous(false positive) results.
Action
Life Technologies is advising users to discard any remaining product of the affected lot.
A product hold has been placed on future stock, and a credit will be provided for all affected stock.
A review of previously generated test results should be performed at the discretion of the laboratory Director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer has identified that when more than one beam is defined on the same isocenter, the center beam in field (cbf) affects all beams in a way that the user may not expect.After using cbf, the resulting fields are clearly displayed in raystation/rayplan for review and approval. however, one mistreatment incident using the cbf functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery.
Action
Emergo will be contacting users to update to the next version of RayStation/RayPlan.
In the interim, users are advised:
· Be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended.
· Do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam.