Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift
This recall has been terminated (originally issued April 16, 2012).
- Company
- Kci Usa, Inc.
- Recall Initiated
- April 6, 2012
- Posted
- April 16, 2012
- Terminated
- June 19, 2012
- Recall Number
- Z-1431-2012
- Quantity
- 4 units
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.
Distribution
USA Nationwide Distribution including the states of ID and FL
Lot / Code Info
Models 412045-01 & 412046-01. Serial Numbers PRNK00001, PRNK00002, PRNK00003, PRNK00004, PRNK00006, PRNK00007, PRJK00001, PRJK00002, PRXK00001, PRXK00002, and PRXK00003.
Root Cause
Device Design
Action Taken
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.