Recall Z-0612-2024 ยท FNL Bed, Ac-Powered Adjustable Hospital
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
| Date | Dec 22, 2023 (initiated Aug 29, 2023) |
| Status | Open, Classified |
| Reason | Unintended movement of bed wheels |
| Root cause | Device Design |
| Action | Arjo issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 08/29/2023 via US mail. The notice explained the problem with the device and provided instructions for risk mitigation until a permanent technical solution to the issue is available. |
| Quantity | 846 units |
| Distribution | US: TN, CA, NY, IL, NV, PA, SD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.