Events

Recall of MRINNERVU ENDORECTAL COILS

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
    53213
  • Event Risk Class
    II
  • Event Initiated Date
    2008-09-26
  • 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 center conductor of the rg316 cable was found to be ferrous and therefore magnetic instead of copper-based material. the coaxial cable is used inthe bpx 30 ecoils.

Device

MRINNERVU ENDORECTAL COILS
  • Model / Serial
    Model Catalog: BPX 30 (Lot serial: BPX30004583 thru BPX30005642); Model Catalog: BPX 30 (Lot serial: 79783 81119 82259)
  • Product Description
    Medrad 3.0T Prostate eCoil
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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