Events

Safety Alert for X-ray Imaging System O-ARM 1000

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Navigation Inc.

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
  • Event ID
    I1607-282
  • Event Number
    2009EBC-0005097
  • Date
    2016-07-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has identified that the referenced equipment requires some updates to continue to comply with the current operating standards, which include software updates to correct technical and hardware changes to the battery pack, leading to potential adverse events being presented to patients.

Device

X-ray Imaging System O-ARM 1000
  • Model / Serial
    O-ARM 1000, serial 00703.
  • Product Description
    The O-ARM® system is a multidimensional surgical imaging platform optimized for use in spine surgeries and surgeries related to orthopedic trauma. It brings intraoperative image projection to a new level with superior quality of the image and visual field in 2 and 3 dimensions, allowing the surgeon to confirm the accuracy of advanced surgical procedures before the patient leaves the operating room. Integrating seamlessly with navigation, the O-ARM ® SYSTEM reduces x-ray exposure, increasing safety for both medical personnel and patients.
  • Manufacturer
    Medtronic Navigation Inc

Manufacturer

Medtronic Navigation Inc
  • 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
    NIDFSINVIMA