Medical Device
Manufacturing
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Z-0452-2024Class II

Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight...

Ihb Operations / initiated 2023-07-19 / Open, Classified / root cause: design

IHB OPERATIONS B.V. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Weakened connection point on the adjustable suspension arm, potentially causing damage or a break". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-0452-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Ihb Operations
Product
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.
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
1,497
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 codes and lots
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).

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0452-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0452-2024Class IIOngoingVoluntary: Firm initiated