FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1431-2012
- Recalling firm
- KCI USA, Inc.
- Product
- Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift
- Status
- Terminated
- Initiated
- 2012-04-06
- Posted
- 2012-04-16
- Terminated
- 2012-06-19
- 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
- Lot, serial or model codes
- Models 412045-01 & 412046-01. Serial Numbers PRNK00001, PRNK00002, PRNK00003, PRNK00004, PRNK00006, PRNK00007, PRJK00001, PRJK00002, PRXK00001, PRXK00002, and PRXK00003.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 1625774
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28