Medical equipment, implants, and diagnostic devices
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Complaints that the ratchet teeth of the tube are not latching onto the rod.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.
Philips Medical Systems (Cleveland)
Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
BioHorizons Implant Systems
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Windstone Medical Packaging
AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.