Events

Recall of Device Recall P440 Portable 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
    71376
  • Event Risk Class
    Class 2
  • Event Number
    Z-2269-2015
  • Event Initiated Date
    2015-06-24
  • Event Date Posted
    2015-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137522
  • 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
    There is a potential the sling loops may not stay attached to the carry bar hooks.
  • Action
    Prism Medical sent a Field Safety Notice to affected customers via certified first class US mail. The notice identified the affected product, problem and actions to be taken. For questions contact your local Prism Medical dealer or Prism Medical Customer Service Representative 1-800-891-6502

Device

Device Recall P440 Portable Lift
  • Model / Serial
    All serial numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of:Canada, Great Britain, Australia, South Korea, and Japan.
  • Product Description
    Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). || Product Usage: || The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member.
  • 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