Events

Recall of Device Recall GE Aisys

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge Healthcare, Llc.

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
    55355
  • Event Risk Class
    Class 1
  • Event Number
    Z-1526-2010
  • Event Initiated Date
    2010-03-12
  • Event Date Posted
    2010-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90650
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Anesthesia Machine and Monitor - Product Code BSZ
  • Reason
    Unanticipated shut-down: a specific lot of ge healthcare aisys and avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Device

Device Recall GE Aisys
  • Model / Serial
    Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
  • Manufacturer
    Ge Healthcare, Llc

Manufacturer

Ge Healthcare, Llc
  • Manufacturer Address
    Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA