IHB OPERATIONS B.V. recalls Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

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.

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

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.

• FDA enforcement recordOfficial FDA database entry for Z-1663-2025
• FDA device classification · FQOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4960The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find IHB OPERATIONS B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.