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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Presence of misleading label statements on the product label.
Presence of misleading label statements on the product label.
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
Presence of misleading label statements on the product label.
Presence of misleading label statements on the product label.
Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Distributed sample collection kit with an unapproved instruction for use.
Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
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.
Product that was built for design verification testing was inadvertently distributed to customers.
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.