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Freedom Boom models series: F110, F120, F130, F320, F330… recallZ-0452-2024 · Ihb Operations B.V. · initiated Jul 19, 2023

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

Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

FDA root cause category: Device Design

What the company is doing

A recall notification issued October 09, 2023 via certified mail . Follow-up will be made by service representatives within 2 weeks to arrange for correction to replace all bearing assemblies in the field with an updated design. Prior to the field correction, inspect your Freedom 42A Lightweight Spring Arm for any movement in the end bearing assembly. If any loose connections are identified, please immediately remove the Spring Arm from use and notify your local authorized representative. Address questions or concerns to your local authorized representative or Skytron at 1-800-759-8766.

Recall details

Recall number
Z-0452-2024
Status
Open, Classified
Initiated by the company
Jul 19, 2023
Posted by the FDA
Dec 1, 2023
Recalling firm
Ihb Operations B.V.
Quantity
1,497
Product code
FQO
Distribution
US: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MB, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV.

Product description

Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

Code information (models, lots, serial numbers)

UDI-DI: 10841736115951 (F110 SERIES), UDI-DI: 10841736115968 (F120 SERIES), UDI-DI: 10841736115975 (F130 SERIES), UDI-DI: 10841736116491 (F320 SERIES), UDI-DI: 10841736116545 (F330 SERIES), UDI-DI: 10841736116576 (F350 SERIES), UDI-DI: 10841736116590 (F410 SERIES), UDI-DI: 10841736116651 (F420 SERIES).

Devices named in this recall

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

Sources and updates

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