Recall of PERMOBIL POWERED WHEELCHAIR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PERMOBIL 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
    32827
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-18
  • Event Country
  • 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
    This correction decision has been made because of a potential failure of the top plate which is the component that connects the seating system of the wheelchair to the base. a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. out of 71 cases reported to the fda 3 serious injuries occurred (2 broken bones/1 laceration).

Device

  • Model / Serial
    Model Catalog: C500 BASE ONLY (Lot serial: > 10 numbers contact mfg.); Model Catalog: C500 CORPUS II LR (Lot serial: > 10 numbers contact mfg.); Model Catalog: C500 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C400 CORPUS II LR (Lot serial: > 10 numbers contact mfg.); Model Catalog: C400 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C300 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C350 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C300 BASE ONLY (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    PERMOBIL POWERED WHEELCHAIR
  • Manufacturer

Manufacturer

  • Manufacturer Address
    AURORA
  • Manufacturer Parent Company (2017)
  • Source
    HC