U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Implant, Cochlear - Product Code MCM
Reason
All unimplanted clarion and hiresolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
Action
Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Implant, Cochlear - Product Code MCM
Reason
All unimplanted clarion and hiresolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
Action
Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Sterility may be compromised. the inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch.
Action
The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.
Action
Service representatives were sent a service bulletin dated 8/12/03 instructing them to correct units in the field bearing serial numbers between 20 and 109.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.
Action
Service representatives were sent a service bulletin dated 8/12/03 instructing them to correct units in the field bearing serial numbers between 20 and 109.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Unit, Cryosurgical, Accessories - Product Code GEH
Reason
Cryogen can escape from canister through the seal ring.
Action
The recalling firm issued letters to their customers informing them of an enhancement available for the product. The letters are not dated but were issued between 5/02 and 3/04
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Unit, Cryosurgical, Accessories - Product Code GEH
Reason
Cryogen can escape from canister through the seal ring.
Action
The recalling firm issued letters to their customers informing them of an enhancement available for the product. The letters are not dated but were issued between 5/02 and 3/04
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Reason
There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
Action
A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Extractable Antinuclear Antibody, Antigen And Control - Product Code LLL
Reason
An error in the bio-tek elx800 microplate reader programming specifications for the ena screen assay exists in that an equivocal (borderline) zone is missing.
Action
Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DBM
Reason
The data reduction program written for a specific automated microtiter plate instrument (bio-tek elx800 reader) was found to be faulty. this program is used to calculate the cut off values for diastat anti-mitochondrial antibody kit. program should include a borderline specification to indicate repeat testing is needed.
Action
A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The data reduction program written for a specific automated microtiter plate reader (bio-tek elx800) was found to be faulty. this program is used to calculate the cut off values for the diastat anti-thyroglobulin kit assay. the negative control upper limit should be less than 0.95, rather than less than 1.0.
Action
Customers were sent a notification letter directing customers to check historical data for negative control results reading greater than 0.95 but less than 1.0. These results are invalid and patient results should not have been reported. Customers are instructed to verify negative control manually until new software version is installed. An effectiveness check form is requested to be returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The software program written for use in the automated microtiter plate reader (bio-tek elx800) for use with the pro-trac ii tacrolimus elisa kit was found to be faulty. assay software program did not include the calibrator zero od specification (stdo>=1.500) as specified in the product insert.
Action
Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
Reason
A problem with software for the polytiter immunofluorescent titration system in that no flags or warnings appear when polytiter calibrator values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. the graph may appear valid; however erroneous results may occur.
Action
Customers were sent a Technical Bulletin describing the correct procedure to be used when entering data into the Poly/Titer tiration system, until the updated software is installed
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Lift, Patient, Ac-Powered - Product Code FNG
Reason
Incorrect length support screws may cause patient lift failure.
Action
Liko notified Peridot Group by letter dated 9/29/04 of the recall. All Canadian distributors, including Peridot, will contact and inspect and replace bolts at user sites.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Lift, Patient, Ac-Powered - Product Code FNG
Reason
Incorrect length support screws may cause patient lift failure.
Action
Liko notified Peridot Group by letter dated 9/29/04 of the recall. All Canadian distributors, including Peridot, will contact and inspect and replace bolts at user sites.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Lift, Patient, Ac-Powered - Product Code FNG
Reason
Incorrect length support screws may cause patient lift failure.
Action
Liko notified Peridot Group by letter dated 9/29/04 of the recall. All Canadian distributors, including Peridot, will contact and inspect and replace bolts at user sites.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Tube Mount, X-Ray, Diagnostic - Product Code IYB
Reason
Some versarad systems have a faulty weld that may result in oil leakage.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
Action
Dunlee sent recall letters dated 4/4/05 to end user locations, informing them that Dunlee and their service representatives would visit each location to replace the mounting bolts on all Dunlee DA-200 Performix installations because of problems experienced at certain GE CT installations. Any questions were directed to John M. Macko, Product Marketing Manager, at 630-585-2174.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Grid, Radiographic - Product Code IXJ
Reason
Screens may be affected with image artifacts.
Action
Letters mailed 4/8/2005. Customers informed of the problem and advised that Kodak representatives will exchange the recalled screens for new screens.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Laparoscope, General & Plastic Surgery - Product Code GCJ
Reason
The expiration date listed on the product label is greater than the vendor recommended expiration date.
Action
Consignees were notified by certified mail on 04/01/2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Laparoscope, General & Plastic Surgery - Product Code GCJ
Reason
The expiration date listed on the product label is greater than the vendor recommended expiration date.
Action
Consignees were notified by certified mail on 04/01/2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
Action
Press release issued 4/28/2005. Letters to customers issued 4/29/2005. The letters sent via First Class Mail and are flagged: "URGENT RECALL NOTIFICATION". Customers instructed to order alternative electrode/cable solutions from Philips Medical Systems; discontinue clinical use of Adapter Cables; discard cables or use them for training purposes only.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Glucose Oxidase, Glucose - Product Code CGA
Reason
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'c' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the a/c adaptor without batteries.
Action
Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Glucose Oxidase, Glucose - Product Code CGA
Reason
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'c' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the a/c adaptor without batteries.
Action
Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Glucose Oxidase, Glucose - Product Code CGA
Reason
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'c' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the a/c adaptor without batteries.
Action
Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.