Recall Z-0010-2014 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
| Date | Oct 15, 2013 (initiated Aug 28, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrm ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 8/28/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 28, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager and director of Biomedical / clinical engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (1-800-345-2700 US). |
| Quantity | 911 (252 US, 659 OUS) |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of US: AK, AZ, CA, CO, DE, FL, GA, IL, KY, LA, MD, MI, MN, MS, MT, NV, NY, NC, OH, OR, PA, SC, TX, WY, and WI and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COST ARICA, CROATIA, CZECH R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110213 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc., Jul 20, 2011 |
| K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 Datex-Ohmeda, Sep 9, 2011 |
| K112722 | GE DATEX-OHMEDA AVANCE Datex-Ohmeda, Inc., Dec 16, 2011 |
| K122445 | AESPIRE 7900, AESPIRE VIEW Datex-Ohmeda, Oct 12, 2012 |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 Datex-Ohmeda, Inc., Feb 6, 2013 |