Terminated

GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.

FDA Recall Z-0010-2014 · Posted 2013-10-15

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeBSZ

Date Initiated2013-08-28

Date Terminated2015-01-30

Product Quantity911 (252 US, 659 OUS)

Reason for Recall

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

Firm 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).

Root Cause

Nonconforming Material/Component

Distribution Pattern

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 REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KAZAHHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LITHUANIA, MAURITITUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPINES, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, and VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123125GE DATEX-OHMEDA AVANCE CS2Datex-Ohmeda, Inc. · 2013-02-06 K122445AESPIRE 7900, AESPIRE VIEWDatex-Ohmeda · 2012-10-12 K112722GE DATEX-OHMEDA AVANCEDatex-Ohmeda, Inc. · 2011-12-16 K111116ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011-09-09 K110213GE DATEX-OHMEDA AISYSDatex-Ohmeda, Inc. · 2011-07-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.