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
    107620
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-15
  • 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
    It was discovered at the o'hara site that operation manual cds for spectris solaris ep (ssep) were not sent to customers. the operation manual multilingual cd was intended to be placed on the product proposal which would have the manual shipped with the spectris solaris ep injector as a line item. the cd was never added to the product proposal.

Device

SPECTRIS EP MR INJECTION SYSTEM
  • Model / Serial
    Model Catalog: 3012011 (Lot serial: 201690); Model Catalog: 3012011 (Lot serial: 201362); Model Catalog: 3012011 (Lot serial: 201380); Model Catalog: 3012011 (Lot serial: 201855); Model Catalog: 3012011 (Lot serial: 201643); Model Catalog: 3012011 (Lot serial: 201867); Model Catalog: 3012011 (Lot serial: 201630); Model Catalog: 3012011 (Lot serial: 201852); Model Catalog: 3012011 (Lot serial: 201851); Model Catalog: 3012011 (Lot serial: 201828); Model Catalog: 3012011 (Lot serial: 201398); Model Catalog: 3012011 (Lot serial: 202054); Model Catalog: 3012011 (Lot serial: 201384); Model Catalog: 3012011 (Lot serial: 201188)
  • Product Description
    SPECTRIS EP MR INJECTION SYSTEM
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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