FDA Medical Device Recalls (openFDA)
IHB OPERATIONS B.V.: Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
- Recall number
- Z-1663-2025
- Recalling firm
- IHB OPERATIONS B.V.
- Product
- Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
- Status
- Open, Classified
- Initiated
- 2025-03-27
- Posted
- 2025-04-23
- Terminated
- not on file
- 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 corrected on site. Skytron notified the medical facilities (users of the device) by issuing an URGENT: MEDICAL DEVICE RECALL notice on 03/28/2025 via US Mail. This letter explained the issue, risk to health and requested the following: Actions to be taken by Customer/User: Prior to the field correction, you should take the following precautionary measures to mitigate any potential risks: Inspect your 4FXS-60 frames to ensure that all 4 mounting screws are secure. If any loose connections are identified, immediately remove the 4FXS-60 from use and notify your local authorized representative. For questions or concerns, please contact your local authorized representative or Skytron at 1-800-759-8766.
- 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.
- Lot, serial or model codes
- UDI/DI 10841736116071, All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQO
- Firm FEI
- 3006800085
- Firm city
- Zwolle
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28