Recall Z-2479-2021 ยท FSA Lift, Patient, Non-Ac-Powered
Arjohuntleigh Magog, Inc.
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
| Date | Mar 4, 2021 |
| Status | Terminated |
| Reason | The spreader bar can disconnect from the scale bottom attachment. |
| Root cause | Under Investigation by firm |
| Action | Customers identified as owners of the affected scales will be notified of the identified product risk and the Field Safety Corrective Action through the Field Safety Notice. Affected customers need to ensure that all caregivers and users of the affected devices are made aware of the Field Safety Notice. There will be two options for customers: - Contact Arjo to order parts and instruction required to proceed with the disconnection of the affected scale by on-site biomed personnel to continue to use the ceiling lift safely, or - Contact Arjo to ask to an Arjo service technician to visit a cust |
| Quantity | 62 units |
| Distribution | Distribution in US - AZ, CA, CO, IL, LA, MA, MI, MO, OH, PA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.