Events

Recall of Device Recall Cool/Heat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMF Support Surfaces 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
    31050
  • Event Risk Class
    Class 2
  • Event Number
    Z-0844-05
  • Event Initiated Date
    2005-01-27
  • Event Date Posted
    2005-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37067
  • 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
    System, Thermal Regulating - Product Code DWJ
  • Reason
    Operator misconnected device power cords causing failure of the device.
  • Action
    Recall letters dated January 28, 2005, wee sent to consignees with instructions that a new control unit was being sent to their attention and directions for return of the previous control units.

Device

Device Recall Cool/Heat
  • Model / Serial
    Unit Serial Numbers  1020V0503E00174  1020V0304E00058  1020V0403E00145  1020V0203E00102  1020V0503E00088  1020V0403E00153
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    IN, MD, ND
  • Product Description
    Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress)
  • Manufacturer
    AMF Support Surfaces Inc

Manufacturer

AMF Support Surfaces Inc
  • Manufacturer Address
    AMF Support Surfaces Inc, 1691 N Delilah St, Corona CA 92879-1885
  • Source
    USFDA