Events

Recall of Zuma Mobility System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by KCI USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61547
  • Event Risk Class
    Class 2
  • Event Number
    Z-1431-2012
  • Event Initiated Date
    2012-04-06
  • Event Date Posted
    2012-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108401
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lift, patient, non-ac-powered - Product Code FSA
  • Reason
    The zuma mobility assist and trainer have the potential to bind during lowering operation.
  • 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.

Device

Zuma Mobility System
  • Model / Serial
    Models 412045-01 & 412046-01. Serial Numbers PRNK00001, PRNK00002, PRNK00003, PRNK00004, PRNK00006, PRNK00007, PRJK00001, PRJK00002, PRXK00001, PRXK00002, and PRXK00003.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of ID and FL
  • Product Description
    Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. || Product Usage: Human Non-AC-Powered Patient Lift
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.
  • Manufacturer Address
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA