Events

Safety Alert for O-arm Imaging Systems

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

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
    2013-01-28
  • Event Date Posted
    2013-01-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130128a.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 imaging systems medical device manufacturer, medtronic ltd., has issued a field safety notice concerning o-arm imaging systems. the affected serial numbers are from 101 to 564. the manufacturer has identified a potential failure in the braking system that controls the o-arm gantry’s vertical movement. this potential failure exists when the o-arm gantry is in a raised position, and could result in an uncontrolled descent when the up/down button is released. the gantry would stop when coming to rest on the hard stop on the horizontal frame of the device or reaching the end of travel (which could include contact with the patient and/or protruding instrumentation within the bore of the system). according to the manufacturer, this potential failure has no impact on the amount of radiation emission delivered by the system, and there have been no reports of this or similar events occurring at any customer site. if the transistor component fails, the gantry could experience an uncontrolled descent until coming to rest on the hard stop on the horizontal frame of the device or reaching the end of travel. the falling gantry could contact the patient, or protruding instrumentation within the bore of the system. this has the potential to result in serious injury or death to the patient, or injury to users, or both. the manufacturer will implement an improved circuit for the braking system that controls the o-arm gantry’s vertical movement. this improved circuit will be implemented by replacing the motion control box on all affected o-arm imaging systems. furthermore, the manufacturer advises that the risk of the adverse health consequences described can be reduced by setting the or table/patient height from the floor as low as possible. according to the local supplier, medtronic international limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 january 2013.

Device

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

Manufacturer

Medtronic Ltd.
  • 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