Z-0678-2016Class II

GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in...

Name: Z-0678-2016 GE Healthcare, Aestiva 7900, 1006-9305-000. 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 7900, 1006-9305-000. 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-0678-2016
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 7900, 1006-9305-000. 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.
Product code: CBK Ventilator, Continuous, Facility Use
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: 2
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: AMRU01022 AMRU01023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0678-2016
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 CBK

K023366Class IIDatex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. / cleared 2003-10-07

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)