Events

Recall of BIOS ROLLATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by THERMOR LTD..

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
    22919
  • Event Risk Class
    I
  • Event Initiated Date
    2012-02-10
  • 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
    Initial compliant was brought to thermor ltd's attention on december 22 2011 when a customer suffered a minor fall which resulted in very minor injury while using the device. the second complaint was registered on december 23 2011. the recall was initiated due to manufacturer's defect which could result in the fracturing of metal welds.

Device

BIOS ROLLATOR
  • Model / Serial
    Model Catalog: 56001 (Lot serial: 1110-13870)
  • Product Description
    BIOS ROLLATOR
  • Manufacturer
    THERMOR LTD.

Manufacturer

THERMOR LTD.
  • Manufacturer Address
    NEWMARKET
  • Manufacturer Parent Company (2017)
    Thermor Ltd
  • Source
    HC