Events

Safety Alert for O-arm 1000 Imaging Systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-09-10
  • Event Date Posted
    2018-09-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180910.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic o-arm 1000 imaging systems medical device manufacturer, medtronic, has issued a medical device safety alert concerning all 2nd edition o-arm 1000 imaging system. the affected devices are identified as follow: product names (catalogue number) oarm assy bi70000027 system product (bi70000027) oarm assy bi70000027r sys product rwk (bi70000027r) base oarm bi70000027100 system 100v (bi70000027100) base oarm bi70000027100r system 100v rwk (bi70000027100r) base oarm bi70000027120 system 120v (bi70000027120) base oarm bi70000027120r system 120v rwk (bi70000027120r) base oarm bi70000027230 system 230v (bi70000027230) base oarm bi70000027230r system 230v rwk (bi70000027230r) oarm assy bi70000027ger sys product ger (bi70000027ger) oarm assy bi70000027gerr sys product refurb (bi70000027gerr) the manufacturer released software version 3.1.7. the change is in response to customer complaints and addresses several known software anomalies. the software anomalies were reported to affect the following system functionalities: startup and shutdown system and network communication motion control image acquisition and output dose reporting logs generation according to the manufacturer, over the last six years, five complaints led to cancelled procedures after the patient was under anaesthesia requiring additional surgery. the field action is being initiated to address the issues relating to these complaints. the local supplier will contact affected users to schedule completion of the software install. the affected users may choose to continue to use their 2nd edition o-arm 1000 imaging system at their clinical discretion in the meantime, but they should be aware of the issues described above, which may result in a delayed surgery, patient exposure to non-navigated surgery, patient exposure to additional surgery or unused x-ray dose. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 10 september 2018.

Device

O-arm 1000 Imaging Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic O-arm 1000 Imaging Systems
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH