Recall Z-1861-2021
Skytron, Div. The KMW Group, Inc · initiated May 11, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Serial Numbers: 1504-314-00-1-0002 up to 2006-314-00-1-0185 ***UPDATED 12/10/21*** Recall expanded to include Rev 3. Complete list of recalled Serial Numbers: 1504-314-00-1-0002 1504-314-00-1-0003 1504-314-00-1-0004 1508-314-00-1-0005 1508-314-00-1-0006 1508-314-00-1-0007 1508-314-00-1-0008 1509-314-00-1-0009 1509-314-00-1-0010 1509-314-00-1-0011 1509-314-00-1-0012 1510-314-00-1-0013 1510-314-00-1-0014 1601-314-00-1-0016 1601-314-00-1-0017 1610-314-00-1-0018 1610-314-00-1-0019 1610-314-00-1-0020 1610-314-00-1-0021 1610-314-00-1-0022 1610-314-00-1-0023 1610-314-00-1-0024 1610-314-00-1-0025 1610-314-00-1-0026 1610-314-00-1-0027 1610-314-00-1-0028 1610-314-00-1-0029 1610-314-00-1-0030 1610-314-00-1-0031 1610-314-00-1-0032 1802-314-00-1-0033 1802-314-00-1-0034 1802-314-00-1-0035 1802-314-00-1-0036 1802-314-00-1-0037 1802-314-00-1-0038 1802-314-00-1-0039 1802-314-00-1-0040 1802-314-00-1-0041 1802-314-00-1-0042 1803-314-00-1-0043 1803-314-00-1-0044 1803-314-00-1-0045 1803-314-00-1-0046 1803-314-00-1-0047 1803-314-00-1-0048 1803-314-00-1-0049 1803-314-00-1-0050 1803-314-00-1-0051 1803-314-00-1-0052 1809-314-00-1-0053 1809-314-00-1-0054 1809-314-00-1-0055 1809-314-00-1-0056…
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
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1861-2021
- Initiated
- May 11, 2021
- Posted by FDA
- June 15, 2021
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Quantity
- 278 units US; 7 units OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Japan.
- Recalling firm
- Skytron, Div. The KMW Group, Inc, Grand Rapids, MI