Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch

FDA device recall Z-1861-2021 · posted 2021-06-15 · Open, Classified

Recall details

Recalling firm

Skytron, Div. The KMW Group, Inc

Reason for recall

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

Action taken

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 with any questions. ***UPDATED 12/10/21*** On November 22, 2021, the firm sent updated letters due to an expansion of the recall scope. Revision 3 models of the FS32 Monitor Bracket were added to the recall. Customer instructions remain the same.

Root cause

Device Design

Status

Open, Classified

Product code

FQO

Quantity affected

278 units US; 7 units OUS

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Japan.

Date initiated

2021-05-11

Date posted

2021-06-15

Location

Grand Rapids, MI