Events

Recall of AISYS CARESTATION ANESTHESIA SYSTEM - 7900 SYSTEM SOFTWARE

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
    107424
  • Event Risk Class
    II
  • Event Initiated Date
    2009-02-17
  • 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
    Failure of the electrical portion of the on/standby switch causes the system to shutdown without clinical intervention causing the patient to experience hypoventilation leading to hypoxia.

Device

AISYS CARESTATION ANESTHESIA SYSTEM - 7900 SYSTEM SOFTWARE
  • Model / Serial
    Model Catalog: 1011-8109-000 (Lot serial: ANAK00112 ANAK00113); Model Catalog: 1011-8109-000 (Lot serial: ANAK00110 ANAK00111); Model Catalog: 1011-8109-000 (Lot serial: ANAK00114 ANAK00115); Model Catalog: 1011-8109-000 (Lot serial: S/N'S ANAJ00131 ANAJ00133); Model Catalog: 1009-8134-000 (Lot serial: >100 NUMBERS); Model Catalog: 1009-8134-000 (Lot serial: CONTACT); Model Catalog: 1009-8134-000 (Lot serial: MANUFACTURER); Model Catalog: 1011-8302-000 (Lot serial: >10 NUMBERS); Model Catalog: 1011-8302-000 (Lot serial: CONTACT); Model Catalog: 1011-8302-000 (Lot serial: MANUFACTURER); Model Catalog: 1011-9000-000 (Lot serial: S/N'S ANAH001122 & ANAJ00132); Model Catalog: 1009-9002-000 (Lot serial: ANBM00367 ANBH00291); Model Catalog: 1009-9002-000 (Lot serial: S/N'S ANBL01967 ANBL01990)
  • Product Description
    AISYS ANESTHESIA CARESTATION
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)