Recall Z-1861-2021 ยท FQO Table, Operating-Room, Ac-Powered
Skytron, Div. The KMW Group, Inc
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
| Date | Jun 15, 2021 (initiated May 11, 2021) |
| Status | Open, Classified |
| Reason | Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff |
| Root cause | Device Design |
| Action | Skytron issued Urgent Medical Device Correction notice on 5/11/21. Letter states reason for recall, health risk and action to take: Identify your FS32 monitor bracket(s). Serial numbers can be found on the UDI label located on the back of the bracket. Inspect your FS32 monitor bracket(s) per the instructions on the final page of this document. Remove from service any bracket where evidence is identified that the device may fail. Skytron authorized representatives have been directed to contact you and schedule a service visit. Please contact Erin Woolf, at 616-656-2998 or ewoolf@skytron.us w |
| Quantity | 278 units US; 7 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.