Events

Recall of SPECTRIS EP MR INJECTION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER MEDICAL CARE INC..

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
    104521
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-16
  • 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 battery/cable power assemblies in spectris solaris ep mr injection systems (ssep) distributed from september - november 2016 do not meet our specifications. this could result in intermittent power failure of the device which could result in a degraded image or a delay of the imaging procedure requiring a repeat of the contrast-enhanced mr scan should it occur during a procedure.

Device

SPECTRIS EP MR INJECTION SYSTEM
  • Model / Serial
    Model Catalog: 3012011 (Lot serial: SN 202054)
  • Product Description
    SPECTRIS EP MR INJECTION SYSTEM
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Manufacturer Address
    PITTSBURGH
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC