Recall Z-1098-2022 ยท FSA Lift, Patient, Non-Ac-Powered
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Sara Plus Active Floor Lift
| Date | May 21, 2022 (initiated Apr 5, 2022) |
| Status | Terminated |
| Reason | The device may emit smoke or ignite. |
| Root cause | Device Design |
| Action | A customer letter was sent to consignees on 04/08/2022. The customer are asked to acknowledge the notification, complete and sign off an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the notification). The notification contains the list of precautionary measures to be taken by caregivers in order to minimize the likelihood of the failure until their lifts are corrected by Arjo. The device correction (including PCB upgrade and cover replacement) is to be performed by Arjo personnel, free of charge. |
| Quantity | 4449 devices |
| Distribution | US Nationwide and Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.