Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human No
FDA device recall Z-1431-2012 · posted 2012-04-16 · Terminated
Recall details
- Recalling firm
- KCI USA, Inc.
- Reason for recall
- The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSA
- Quantity affected
- 4 units
- Distribution
- USA Nationwide Distribution including the states of ID and FL
- Date initiated
- 2012-04-06
- Date posted
- 2012-04-16
- Date terminated
- 2012-06-19
- Location
- San Antonio, TX
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