Medical equipment, implants, and diagnostic devices
Alcon Laboratories Ireland
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
CardioTek BV
Device did not pass electrical safety testing for adequate insulation.
Getinge Usa Sales
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Tandem Diabetes Care
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Draeger Medical
Possible occlusion of filters due to manufacturing error.
Micro Therapeutics
Due to incorrect size and configuration labeling of the detachable coil system.
Due to a potential failed sterilization process.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Olympus Corporation of the Americas
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Olympus Corporation of the Americas
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Olympus Corporation of the Americas
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
cybersecurity vulnerability
The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
cybersecurity vulnerability
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Siemens Healthcare Diagnostics
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
New Standard Device
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.
A Size 2 trial baseplate was assembled with Size 1 instrument sets.