Events

Recall of Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Odin Medical Technologies 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
    56258
  • Event Risk Class
    Class 2
  • Event Number
    Z-2240-2010
  • Event Initiated Date
    2010-07-01
  • Event Date Posted
    2010-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93082
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Magnetic Resonance Diagnostic Device - Product Code LNH
  • Reason
    Electronic box on headstrap may overheat, causing burn to patient.
  • Action
    Customers were notified by letter on 07/07/2010, advising them of the overheating problem and alerting them that a service rep will be visiting to inspect and upgrade any affected FlexiCoils. Questions were referred to 800-595-9709.

Device

Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device
  • Model / Serial
    No lot numbers or serial numbers.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, DC, IL, IN, MD, MI, MN, MO, NE, NJ, NV, NY, OH, OR, WA, and WI. Foreign distribution to Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Korea, Netherlands, Poland, Spain, Russia, Switzerland and Turkey.
  • Product Description
    PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, || Usage: Low field MRI device used to gather cranial images.
  • Manufacturer
    Odin Medical Technologies Ltd.

Manufacturer

Odin Medical Technologies Ltd.
  • Manufacturer Address
    Odin Medical Technologies Ltd., Kochav Yokneam, 1 Hamelacha St., Yokneam Elit Israel
  • 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
    USFDA