Events

Recall of IACS MONITORING SOLUTION WITH C700

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA 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
    59928
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-12
  • 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 infinity acute care system monitoring solution cockpits (iacs monitoring solution with c500 and iacs monitoring solution with c700) with revision index 6 or higher that contain 4gb ram modules may induce a failure that can lead to high memory usage thereby delaying touchscreen operations and may also lead to not annunciating audio or visual alarms on the cockpit and infinity central station. the m540 will still issue visual alarms.

Device

IACS MONITORING SOLUTION WITH C700
  • Model / Serial
    Model Catalog: MS25520 (Lot serial: 354380009); Model Catalog: MS25520 (Lot serial: 352066008); Model Catalog: MS25520 (Lot serial: 350603074); Model Catalog: MS25510 (Lot serial: 376587013); Model Catalog: MS25510 (Lot serial: 402073021); Model Catalog: MS25510 (Lot serial: 402073067); Model Catalog: MS25510 (Lot serial: 402073030)
  • Product Description
    IACS MONITORING SOLUTION WITH C700;IACS MONITORING SOLUTION WITH C500
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.