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Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount recallZ-1663-2025 · Ihb Operations B.V. · initiated Mar 27, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ihb Operations B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-1663-2025
Status
Open, Classified
Initiated by the company
Mar 27, 2025
Posted by the FDA
Apr 23, 2025
Recalling firm
Ihb Operations B.V.
Quantity
112 units
Product code
FQO
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 description

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

Code information (models, lots, serial numbers)

UDI/DI 10841736116071, All Serial Numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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