Recall Z-1663-2025 ยท FQO Table, Operating-Room, Ac-Powered
IHB OPERATIONS B.V.
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
| Date | Apr 23, 2025 (initiated Mar 27, 2025) |
| Status | Open, Classified |
| Reason | The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column. |
| Root cause | Process change control |
| Action | Skytron issued a Field Correction notice to its service personnel on 03/27/2025 via email. The notice explained the issue, risk to health, and requested the following: Customer Acknowledgement 1. Contact customers to ensure they have received the customer letter. 2. Provide a copy of the customer letter if needed. 3. Document who you spoke with and the date of contact on the Customer Acknowledgement Spreadsheet. Customer Acknowledgement Spreadsheet will be provided by Quality. 4. Return the completed Customer Acknowledgement Spreadsheet to quality@skytron.com. The devices will be correcte |
| Quantity | 112 units |
| Distribution | US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NM, NY, PA, TN, TX, UT, VA, WI, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.