Events

Recall of EPIC+ (MODEL 2030)

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
    87599
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-23
  • 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 medical has become aware that the stryker critical care beds were reportedly displaying symptoms of unsmooth and noisy fowler motion. continuous use could potentially result in a situation in which the manual cpr drop on the bed may become inoperable at fowler angles of approximately 45 degrees or more.

Device

EPIC+ (MODEL 2030)
  • Model / Serial
    Model Catalog: 2030-000-000 (Lot serial: all); Model Catalog: 2040-000-000 (Lot serial: all)
  • Product Description
    INSTRUCTION MANUALS FOR EPIC II AND ZOOM II CRITICAL CARE BEDS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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