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
FDA Recall Z-1861-2021 · Posted 2021-06-15
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Recalling FirmSkytron, Div. The KMW Group, Inc
Recall StatusOpen, Classified
Product CodeFQO
Date Initiated2021-05-11
Product Quantity278 units US; 7 units OUS
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
Firm 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 [email protected] 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
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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