Z-1663-2025Class II

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

Name: Z-1663-2025 Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Creator: Ihb Operations B.v.
Published: 2025-03-27
License: https://open.fda.gov/license/

Ihb Operations / initiated 2025-03-27 / Open, Classified

FDA source

IHB OPERATIONS B.V. began a recall of Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount on 2025-03-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1663-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-27
Posted: 2025-04-23
Recalling firm: Ihb Operations
Product: Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: 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.
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: UDI/DI 10841736116071, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1663-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1663-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-23

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)