Events

Recall of WARMAIR HYPERTHERMIA UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CINCINNATI SUB-ZERO PRODUCTS.

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
    28293
  • Event Risk Class
    III
  • Event Initiated Date
    2011-09-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The manufacturer has discovered a problem with warmair 135 convective warming devices manufactured between mar 2003 and nov 2010. the manufacturer discovered the printed circuit board on those devices is mounted inside the device using metal instead of plastic studs causing devices to not comply with the creepage distance and air clearance requirement outlined in iec 60601-1.

Device

WARMAIR HYPERTHERMIA UNIT
  • Model / Serial
    Model Catalog: 135 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    WARMAIR MODEL 135
  • Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS

Manufacturer

CINCINNATI SUB-ZERO PRODUCTS
  • Manufacturer Address
    CINCINNATI
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    HC