Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 169–180 of 581 recalls
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
The supplier manufactured anatomical left plates with an incorrect thread orientation.
The supplier manufactured anatomical left plates with an incorrect thread orientation.
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ prog…
A certain component of affected devices was not delivered within specification and contained impurities.
A certain component of affected devices was not delivered within specification and contained impurities.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.