Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
We are currently investigating an issue with the products listed below and are providing this urgent
field safety notice to inform you of this occurrence.
detail on affected devices: immunoassay control ia2640 lot 1364ec and immunoassay
premium plus control ia3112 batch 334337 lot 1364ec.
description of the problem: pth stability has been reduced in control lot 1364ec. it is now
recommended that pth is tested immediately after reconstitution.
risk to health: the contents of this letter should be discussed with your medical director. it is
unlikely the error will cause misreporting of patient results as values for pth using this lot would fall
outside of the assigned ranges. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Randox found an error in labeling for two of the above test methods for determining the amount of total protein (in urine). the values for the mean of all instruments are incorrect by a factor of 10. the correct values are given in the table below. the latter does not affect the performance and stability data of the product. instrument-specific values are correct.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Onset of issues such as corrosion can occur rapidly in units older than seven (7) years and may not
be externally visible. joerns healthcare strongly recommends load testing for the oxford dipper is
carried out at each and every six (6) monthly inspection due to the hostile environment in which it
resides and operates. the humid and corrosive nature of pool-side locations can lead to product
deficiencies that may otherwise remain undetected.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
During production of said lot of tb-antigen blood collection tubes, a portion did not meet endotoxin
specification and was scrapped. the remaining portion was released upon additional testing and
packaged in the above mentioned lot numbers of two kit configurations. qiagen has subsequently
changed procedures on the release of tb-antigen blood collection tubes and identified said lot as the
only remaining lot that was partially released that has not yet expired.
to date, there has been no evidence of product performance being impacted for this lot. however we
cannot dismiss the potential for an elevated rate of positivity due to increased endotoxin. in an abundance
of caution the remainder of this lot is being withdrawn. no other lots are impacted.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Respironics california, llc ("respironics") voluntarily performs a patch for any non-invasive philips v60 fan made before september 15, 2015, requiring replacement of the internal fan cable.
respironics started distributing v60 fans in 2009. all v60 models made before september 15, 2015 are subject to this revision.
v60 fans manufactured on or after september 15, 2015 have a different internal cable, so this correction does not apply to them and there is no need to do anything about them.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
After the imaging process, no images were created during bolillian ict software version 4.1.6 bolus tracking. this means that raw data is not available for offline reconstruction.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Because reliability and safety are always at the forefront of philips, we regularly monitor the performance of our products. during recent assessments of the mobile detector holder, we have identified a possible defect that may affect the performance of the equipment under certain conditions. we would like to inform you of the following letter:
• what is the disadvantage and under what conditions it may occur,
• what measures can be taken to prevent or limit the problem,
• what actions philips will address the shortcoming.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
A firmware anomaly inside the detector (4343rc) can cause the detector to
appear ready for acquisition on very short time intervals while it actually is not,
resulting in not correctly acquiring the x-ray image. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
The device’s labeling inaccurately indicates “endotracheal” as a body temperature application site. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement. should the flextemp reusable temperature sensor be inserted into the patient’s trachea, patient infection or airway blockage may occur if any part of the flextemp reusable temperature sensor or flextemp system jacket is left in the patient upon removal, or if the flextemp system jacket is damaged and sterilization compromised. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Philips has recently discovered that the use of a 12-lead ecg monitoring derivative with specific configuration on the affected monitors and modules in these devices does not trigger an st-segment elevation alarm, which could cause treatment delays.
only hexad functionality is affected by the problem. all other ecg monitoring functionality works the way it does
it is indicated.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Philips has recently discovered that when the local configuration setting ‘alarms on’ is modified from its
factory default, in certain software revisions the philips intellivue mx40 patient wearable monitor will disable
generation and delivery of ecg alarms to the philips intellivue information center ix (piic ix) without visual
indication on the piic ix that the ecg alarms have been disabled. this could lead to a delay in treatment.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Philips found that two screws in the system could break, causing the c-arch to slide freely into
longitudinal directions and can be hung.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Philips recently found that some hospital monitors (mx400,
mx430, mx450, mx500, mx550), which have been on continuously for at least three months, shown
outdated curves that do not reflect the patient's current state.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Reconstructed ecg leads viewed or printed at the information center ix may
misrepresent the ecg waveform in specific leads. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Mrx model m3535a with software version f.03.06 and earlier, and model m3536a with version t.00.05 and earlier may stop the automated ready-for-use (rfu) test in an abnormal state when the device is turned off. if this occurs, the rfu indicator window displays a pattern (pictured below) that is not documented in the instructions for use or service manual. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Philips has recently determined that some intellivue nmt patient cables may have a punctual isolation
defect. affected cables could cause burns on the patient skin if used over a period of time.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
The microsoft windows security settings on a small number of impacted systems were incorrectly
configured during the manufacturing process. this misconfiguration can lead to a windows security alert
dialog being displayed when the system is switched from ivus to the ffr/ifr mode. if the user responds
to the dialog by selecting "allow access," [as shown below), the device's network firewall settings will be
modified, opening its network ports to potential unexpected communication from the hospital network to
which the device may be connected.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Philips has determined that there is a possibility of abnormal operation of the heartstart mrx monitor / defibrillator. in extremely rare cases, the following operating patterns may occur on the device:
1. if the pins with which the battery is attached to the device are damaged or dirty, the electrical connection may be poor. when the device is powered only by a battery, the device may not turn on or restart;
2. when the heartstart mrx monitor / defibrillator is disconnected from the power supply and a single battery is used as the sole power source, the following patterns of abnormal device operation may occur:
a. when the user presses the charge button, the device attempts to charge, and after about 20 seconds, displays a "shock equipment malfunction" error message and is unable to perform shock treatment;
b. the promotion may be interrupted without warning. these device performance patterns may occur until the unit is reset. both of these problems can cause a delay in monitoring or treatment.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Volcano is launching a voluntary remedial action on its own, because one problem has arisen with the v3.2.X, v3.3 and v3.4 software versions running on 55 / ssi / core / core mobile systems ("affected systems") . the withdrawal covers only the affected systems.
volcano was aware of the incompatibility between the affected systems and the hospital network scan. in special circumstances b0 the affected system encounters unexpected data from the i2 hospital network for which the system will have to be restarted manually. this condition can occur at any time, even in the middle
procedure on the patient.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Through internal testing and customer complaint investigations, the following xl+
software and hardware issues have been identified:
software:
the xl+ may fail to complete the power on sequence and continuously reboot.
the xl+ may either fail to power up or may shut down unexpectedly.
the xl+ may have a software version that did not reset a fail-safe monitoring
component which could delay of therapy or pacing interruption.
the xl+ may fail to generate verbal prompts in aed mode.
hardware:
the xl+ may have been manufactured with a speaker that may fail.
the battery may not seat properly causing the xl+ to shut down unexpectedly or
remain powered on and not acknowledge or charge the battery.
the xl+ exceeds the allowable radiated emissions level for class b cispr11.
the xl+ ecg signal from leads could be lost and unrecoverable.
the xl+ spo2 signal may lose communication and cause the device to reboot.
the xl+ battery detection system may be disrupted and cause a false low battery
alarm.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Philips respironics trilogy devices operating with the above software versions and with dual prescriptions
enabled may be susceptible to inadvertent change between active prescriptions in response to specific user
interaction. this may occur without requiring user confirmation of the change. however, devices continue to
accurately display the active prescription in the upper left hand corner of the display. the device does not
change spontaneously.
if the user is unaware of the change between prescriptions, this could pose a risk to patients. there have
been no reports of harm or injury associated with this issue. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Resmed has issued an urgent field safety notice that described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomized to a resmed adaptive servo ventilation (asv) therapy compared to the control group. in the patient population with reduced left ventricular ejection fraction (lvef ≤ 45%), 10.0 percent of the asv group experienced a cardiovascular death each year compared to 7.5 percent of the control group, representing a 33.5 percent relative increased risk of cardiovascular mortality (hr=1.335, 95%ci=(1.070, 1.666), p‐value= 0.010). philips is actively evaluating the information provided by resmed and examining if this might impact the medical care of patients who use the philips devices listed above.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
Hospira would like to remind you of the importance of performing the pre-use checks prior to the use of the gemstar infusion pump. hospira has received reports of gemstar infusion pumps failing to power on, or powering off during use, because the battery door was broken or damaged. hospira would like to remind users to inspect the condition of the battery door per the instructions in the system operating manual (som) before use of the device. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
The manufacturer of the 30atm inflatable device perouse medical has informed arcroyal of a possible defect in the primary envelope (blister) that may affect its sterility. in a limited number of cases, a visible crack appeared near the blister near the lever or pressure gauge.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
This field safety corrective action is being conducted due to the risk that the stopoocks blister packaging may contain a hole thus compromising the sterile barrier. should the user be unaware of a hole in the packaging, a transfer of microorganisms from the stopcock to the patient is possible when the clinician touches the stopcock and then onto the sterile field which may result in the patient contracting an infection.