Events

Recall of Device Recall A625 lift

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ErgoSafe Products, LLC (DBA) Prism Medical.

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
    76351
  • Event Risk Class
    Class 2
  • Event Number
    Z-1405-2017
  • Event Initiated Date
    2017-01-30
  • Event Date Posted
    2017-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152953
  • 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 test at max load (625 lbs.) 2 units had straps break prematurely.
  • Action
    The recalling firm called each customer on Jan 30, 2017 to review the recall and schedule a time for the firm to come to their facility to personally swap the recalled product for a new device. The FSNs were sent on Jan 31, 2017.

Device

Device Recall A625 lift
  • Model / Serial
    A6MC000110 A6M0001010 A6M0001011 A6M0001012 A6M0001013 A6M0001014 A6M0001015 A6M0001016 A6M0001017 A6M0001018 A6M0001019 A6M0001020 A6M0001021 A6M0001025 A6M0001026 A6M0001029 A6M0001022 A6M0001023 A6M0001024 A6M0001027 A6M0001028
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to MT and NV; one VA consignee.
  • Product Description
    A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
  • Manufacturer
    ErgoSafe Products, LLC (DBA) Prism Medical

Manufacturer

ErgoSafe Products, LLC (DBA) Prism Medical
  • Manufacturer Address
    ErgoSafe Products, LLC (DBA) Prism Medical, 10888 Metro Ct, Maryland Heights MO 63043-2413
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA