Z-0680-2016Class II

GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide...

Name: Z-0680-2016 GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide...
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, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support... 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-0680-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Posted: 2016-01-21
Terminated: 2016-09-21
Recalling firm: GE Healthcare
Product: GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI 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: 13
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: ANAU00153 ANAU00156 ANAU00152 ANAU00150 ANAU00151 ANAU00154 ANAU00155 ANAU00157 ANAU00158 ANAU00159 ANAU00160 ANAU00180 ANAU00181

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0680-2016
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

K110213Class IIGe Datex-Ohmeda AisysDatex-Ohmeda, Inc. / cleared 2011-07-20

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)