🏥 Medical Devices • 15,809 recalls
Philips Medical Systems (Cleveland)
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Ortho Clinical Diagnostics
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
St Jude Medical
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Centurion Medical Products
Potential for sterile packaging to be compromised
Centurion Medical Products
Potential for sterile packaging to be compromised
Philips Medical Systems (Cleveland)
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts.
Randox Laboratories, Limited
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
Ortho Clinical Diagnostics
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Gk Photonics
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
Philips Medical Systems (Cleveland)
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Failure to comply event due to incorrect labeling of a class 1 laser product.
Ortho Clinical Diagnostics
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Howmedica Osteonics
Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
Ortho Clinical Diagnostics
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Centurion Medical Products
Potential for sterile packaging to be compromised
Centurion Medical Products
Potential for sterile packaging to be compromised