Events

Recall of S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    124099
  • Event Risk Class
    II
  • Event Initiated Date
    2010-05-03
  • 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
    Potential for o2 flush button to become impeded by the work surface & to stick in the open or partially open position resulting in flow of o2 into the breathing system causing dilution of anesthetic agent.

Device

S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 1009-9012-000 (Lot serial: MANUFACTURER); Model Catalog: 1009-9012-000 (Lot serial: CONTACT); Model Catalog: 1009-9012-000 (Lot serial: >10 NUMBERS); Model Catalog: 1009-9002-000 (Lot serial: >10 NUMBERS); Model Catalog: 1009-9002-000 (Lot serial: MANUFACTURER); Model Catalog: 1009-9002-000 (Lot serial: CONTACT); Model Catalog: 1009-9000-000 (Lot serial: AMXL00153 AMXM00411); Model Catalog: 1009-9000-000 (Lot serial: AMXN00185 AMXN00499); Model Catalog: 1009-9000-000 (Lot serial: AMXM01179 AMXL00152); Model Catalog: 1009-9000-000 (Lot serial: AMXL00260 AMXL02044.); Model Catalog: 1009-9000-000 (Lot serial: AMXM00843 AMXM00845)
  • Product Description
    S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)