GE Medical Systems, LLC: Medical Device Recall in 2016 - (Recall #: Z-0679-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.

Product Classification:

Class II

Date Initiated: December 15, 2015

Date Posted: January 27, 2016

Recall Number: Z-0679-2016

Event ID: 72943

Reason for Recall:

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Status: Terminated

Product Quantity: 84

Code Information:

AMTU01048 AMTU01023 AMTU00163 AMTU01050 AMTU00172 AMTU00175 AMTU00176 AMTU01034 AMTU01047 AMTU01055 AMTU01001 AMTU01002 AMTU01021 AMTU01044 AMTU01042 AMTU01015 AMTU00178 AMTU00179 AMTU00162 AMTU01000 AMTU01012 AMTU01041 AMTU00167 AMTU01019 AMTU00177 AMTU01049 AMTU00171 AMTU00164 AMTU01066 AMTU01006 AMTU00168 AMTU01061 AMTU01060 AMTU01056 AMTU01057 AMTU01073 AMTU00154 AMTU00166 AMTU00174 AMTU01005 AMTU01035 AMTU00150 AMTU01024 AMTU01025 AMTU01026 AMTU01027 AMTU01037 AMTU00152 AMTU01040 AMTU01022 AMTU00157 AMTU00158 AMTU00159 AMTU00160 AMTU00170 AMTU01018 AMTU01009 AMTU01032 AMTU01046 AMTU01045 AMTU01020 AMTU01008 AMTU00165 AMTU01013 AMTU01014 AMTU01033 AMTU01016 AMTU01036 AMTU01038 AMTU00151 AMTU00169 AMTU01003 AMTU00161 AMTU01010 AMTU01064 AMTU01011 AMTU01004 AMTU01017 AMTU01031 AMTU01053 AMTU01058 AMTU01059 AMTU01039 AMTU01007

Distribution Pattern:

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

Voluntary or Mandated:

Voluntary: Firm initiated