Events

Recall of EVA 450 Patient Lift Battery Charger

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Romedic, 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
    55659
  • Event Risk Class
    Class 2
  • Event Number
    Z-1736-2010
  • Event Initiated Date
    2010-04-28
  • Event Date Posted
    2010-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91470
  • 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
    Non-AC-powered patient lift. - Product Code FSA
  • Reason
    Incorrect battery chargers were supplied with the eva 450 patient lifts. charger unit stops working and will not charge lift. new chargers were supplied to customers.
  • Action
    The recalling firm sent out a letter with instructions as follows: 1) Locate EVA 450 Patient Lift(s), 2) Fill out Customer Response Form and fax to 888-691-1091, 3) Replace battery charger(s) with new battery charger(s) supplied with this notification; NEW battery charger to be used according to EVA 450 Instructions, 4) Repackage replaced battery charger(s) in original packing in which shipment was recieved, 5) Apply supplied sticker "EVA 450 Battery Charger RECALL" on outside of box, 6) Apply supplied UPS return label on outside of box and contact UPS for pickup and mail to the following Address: RoMedic, Inc., 300 West Chestnut St., Ephrata, PA 17522; Attn: EVA 450 Battery Charger Recall. Additional questions are directed to the company at phone: 888-625-4343.

Device

EVA 450 Patient Lift Battery Charger
  • Model / Serial
    Serial numbers: 373317696102209, 373317696102210, 373317696102224, 373317696102227, 373317696102228, 373317696102232, 373317696102235, 373317696102242, and 373317696102244.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    EVA 450 Patient Lift Battery Charger.
  • Manufacturer
    Romedic, Inc.

Manufacturer

Romedic, Inc.
  • Manufacturer Address
    Romedic, Inc., 300 West Chestnut St., Po Box 388, Ephrata PA 17522
  • Source
    USFDA