š„ Medical Devices ā¢ 4,350 recalls
GE Vingmed Ultrasound As
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
Philips Respironics
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.
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.
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.
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.