Terminated

GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. 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.

FDA Recall Z-0681-2016 · Posted 2016-01-21

Recalling FirmGE Medical Systems, LLC

Recall StatusTerminated

Product CodeBSZ

Date Initiated2015-12-15

Date Terminated2016-09-21

Product Quantity2627

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.

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132530GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)Datex-Ohmeda, Inc. · 2013-12-20 K131945GE DATEX-OHMEDA AVANCE CS2Datex-Ohmeda · 2013-08-08 K112722GE DATEX-OHMEDA AVANCEDatex-Ohmeda, Inc. · 2011-12-16

Official Source

View FDA Recall →

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