Z-1431-2012

Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01

Name: Z-1431-2012 Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01
Creator: KCI USA, Inc.
Published: 2012-04-06
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2012-04-06 / Terminated / root cause: design

FDA source

KCI USA, Inc. began a recall of Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift on 2012-04-06. The reason FDA records is "The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1431-2012
Status: Terminated
Initiated: 2012-04-06
Posted: 2012-04-16
Terminated: 2012-06-19
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
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.
Root cause tag: design
FDA 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 in commerce: 4 units
Distribution: USA Nationwide Distribution including the states of ID and FL
Product codes and lots: Models 412045-01 & 412046-01. Serial Numbers PRNK00001, PRNK00002, PRNK00003, PRNK00004, PRNK00006, PRNK00007, PRJK00001, PRJK00002, PRXK00001, PRXK00002, and PRXK00003.

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)