Events

Recall of ISOAIR SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

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
    81385
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-28
  • 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
    Stryker is the distributor of the isoair system. the specification developer/manufacturer of the isoair system has determined that electrical interference emanating from the system may cause clinically unacceptable levels of signal artifact in electrophysiological monitoring devices e.G. ecg ekg or eeg. this only occurs when the active sensor technology (ast) cable from the air pump is connected to the surface. stryker has received a few complaints associated with this issue.

Device

ISOAIR SYSTEM
  • Model / Serial
    Model Catalog: 2940-000-038 (Lot serial: 15C0036)
  • Product Description
    IsoAir Mattress
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC