Recall Z-1431-2012 ยท FSA Lift, Patient, Non-Ac-Powered
KCI USA, Inc.
Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift
| Date | Apr 16, 2012 (initiated Apr 6, 2012) |
| Status | Terminated |
| Reason | The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation. |
| Root cause | Device Design |
| Action | KCI sent an Urgent - Voluntary Medical Device Correction notification letters dated April 6, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. KCI will contact affected customers to schedule a time to upgrade the device. For questions contact KCL's Customer Technical Service Center at 1-800-275-4524. Select option 3 followed by option 2. |
| Quantity | 4 units |
| Distribution | USA Nationwide Distribution including the states of ID and FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.