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U.S. Department of Health and Human Services

Class 2 Device Recall Skytron Freedom Booms

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 Class 2 Device Recall Skytron Freedom Boomssee related information
Date Initiated by FirmJuly 19, 2023
Date PostedDecember 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0452-2024
Recall Event ID 93351
Product Classification Table, operating-room, ac-powered - Product Code FQO
ProductFreedom 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 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).
FEI Number 3006800085
Recalling Firm/
Manufacturer		 IHB OPERATIONS B.V.
Floresstraat 52
Zwolle Netherlands
For Additional Information ContactLocal Representative
800-759-8766
Manufacturer Reason
for Recall		Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
FDA Determined
Cause 2		Device Design
ActionA 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 Commerce1,497
DistributionUS: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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