Z-0679-2016Class II

GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in...

Name: Z-0679-2016 GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in...
Creator: GE Medical Systems, LLC
Published: 2015-12-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-12-15 / Terminated / root cause: manufacturing process

FDA source

GE Medical Systems, LLC began a recall of 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... on 2015-12-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0679-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Posted: 2016-01-21
Terminated: 2016-09-21
Recalling firm: GE Healthcare
Product: 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 code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated December 15, 2015, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Quantity in commerce: 84
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0679-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0677-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0678-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0679-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0680-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0681-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0682-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21

Product code BSZ

K050055Class IIGe Datex-Ohmeda Aestiva/5 MRI Anesthesia SystemDatex-Ohmeda, Inc. / cleared 2005-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)