š„ Medical Devices ā¢ 4,262 recalls
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.
Megadyne Medical Products
Firm has received reports of patient burns in surgical procedures where device was used.
When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures.
Megadyne Medical Products
Firm has received reports of patient burns in surgical procedures where device was used.
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.
DePuy Mitek, Inc., a Johnson & Johnson
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESSĀæ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESSĀæ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
DePuy Mitek, Inc., a Johnson & Johnson
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESSĀæ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESSĀæ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
DePuy Mitek, Inc., a Johnson & Johnson
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESSĀæ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESSĀæ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
DePuy Mitek, Inc., a Johnson & Johnson
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESSĀæ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESSĀæ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
DePuy Mitek, Inc., a Johnson & Johnson
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESSĀæ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESSĀæ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
PHILIPS HEADQUARTERS CAMBRIDGE
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Ortho-Clinical Diagnostics
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
PHILIPS HEADQUARTERS CAMBRIDGE
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
PHILIPS HEADQUARTERS CAMBRIDGE
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
PHILIPS HEADQUARTERS CAMBRIDGE
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results
ICU Medical
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Smiths Medical ASD
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.