Events

Recall of O-ARM 1000 IMAGING SYSTEM - BASE OARM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA 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
    33717
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-18
  • 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 recall is to address labeling compliance gaps for the o-arm? 1000 service manual and instructions for use. manufacturers of x-ray equipment are required to provide information to the user covering aspects of safety maintenance and performance. the current o1 instructions for use and the o-arm general and advanced service manuals are out of compliance with these requirements. to bring the affected o-arm? systems into compliance manufacturer is providing an errata sheet with the correct information.

Device

O-ARM 1000 IMAGING SYSTEM - BASE OARM
  • Model / Serial
    Model Catalog: BI-700-00027120 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    O-ARM 1000 IMAGING SYSTEM - BASE OARM
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC