Recall Z-0452-2024 ยท FQO Table, Operating-Room, Ac-Powered
IHB OPERATIONS B.V.
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.
| Date | Dec 1, 2023 (initiated Jul 19, 2023) |
| Status | Open, Classified |
| Reason | Weakened connection point on the adjustable suspension arm, potentially causing damage or a break. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.