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
    148955
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-17
  • 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 drive gas check valve could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle. if this issue is left unresolved it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Device

S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 1009-9012-000 (Lot serial: >10 contact mfg.); Model Catalog: 1009-9050-000 (Lot serial: >10contact mfg.); Model Catalog: 1011-9050-000 (Lot serial: >10 contact mfg.)
  • Product Description
    S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - Main Unit
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)