Events

Recall of Device Recall Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems

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
    65164
  • Event Risk Class
    Class 2
  • Event Number
    Z-1443-2013
  • Event Initiated Date
    2013-05-14
  • Event Date Posted
    2013-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118055
  • 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 the reusable co2 absorbent canister accessory used with aespire, aespire view, avance, avance cs2, aisys, adu, 9100, m900, m904, 9300 systems. reusable co2 absorbent canisters accessories may not seal properly.
  • Action
    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter April 30, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Fax back form was included with the letter requesting the consignees to complete and return.

Device

Device Recall Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems
  • Model / Serial
    Canisters with date code of 02-2013 (Feb 2013)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.
  • Product Description
    Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. || Intended to provide general inhalation anesthesia and ventilatory support.
  • 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