Events

Recall of ARJO PARKER BATH SYSTEMS -SPA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ARJO CANADA 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
    88248
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-02
  • 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
    It has been found that the label placed on the affected devices includes incorrect information regarding the input voltage - instead of showing 120v 60hz the one currently on the label is 230v 50hz. the products are technically configured to be compatible with 120v 60hz input voltage therefore the detected problem is unlikely to have any impact on the device operation or performance.

Device

ARJO PARKER BATH SYSTEMS -SPA
  • Model / Serial
    Model Catalog: AL2XXXX-US (Lot serial: all)
  • Product Description
    PARKER BATH
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

ARJO CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC