Events

Recall of Device Recall GE DatexOhmeda Aisys CS2 Anesthesia System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, 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
    73383
  • Event Risk Class
    Class 2
  • Event Number
    Z-1381-2016
  • Event Initiated Date
    2016-02-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143994
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    Ge healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all aisys cs2 and upgraded aisys anesthesia devices.
  • Action
    Consignees were sent on 2/17/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34075 dated February 17, 2016.The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE DatexOhmeda Aisys CS2 Anesthesia System
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.
  • Product Description
    GE Healthcare, Aisys CS2 anesthesia..
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA