Events

Recall of PRISM MEDICAL A625

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Handicare 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
    78096
  • Event Risk Class
    Class 2
  • Event Number
    Z-0013-2018
  • Event Initiated Date
    2017-09-08
  • Event Date Posted
    2017-09-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158653
  • 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
    During internal cycle testing of a-series lifts handicare has found that the a-series lift strap for lifts manufactured between april 25, 2017 and june 12, 2017 may wear prematurely at max load (625 lbs). we have identified the root cause as a supplied component that was not to specification. if the strap wears during use there is a potential risk for the person being supported by the lift to drop.
  • Action
    The firm initiated their recall by email on 09/08/2017. The consignee was warned that the lift straps may wear prematurely and they would be contacted by a representative and the units would be replaced.

Device

PRISM MEDICAL A625
  • Model / Serial
    A6M0001526, A6M0001527, A6M0001528, A6M0001529, A6M0001530, A6M0001485, A6M0001486, A6M0001498
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Us and Canada
  • Product Description
    PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
  • Manufacturer
    Handicare Usa Inc

Manufacturer

Handicare Usa Inc
  • Manufacturer Address
    Handicare Usa Inc, 10888 Metro Ct, Maryland Heights MO 63043-2413
  • Manufacturer Parent Company (2017)
    Handicare Group Ab
  • Source
    USFDA