Events

Recall of Device Recall Microtemp II.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cincinnati Sub-Zero Products 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
    30829
  • Event Risk Class
    Class 2
  • Event Number
    Z-0671-05
  • Event Initiated Date
    2005-01-18
  • Event Date Posted
    2005-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36669
  • 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
    Pack, Hot Or Cold, Water Circulating - Product Code ILO
  • Reason
    There is the potential that the power switch assembly can dislodge from the cabinet during use.
  • Action
    The recalling firm sent letters, dated 1/18/04.

Device

Device Recall Microtemp II.
  • Model / Serial
    All units containing version 0.70 software.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to hospitals throughout the United States.
  • Product Description
    Micro-temp II heat therapy unit, model #747.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Manufacturer Address
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    USFDA