GE Medical Systems, LLC: Medical Device Recall in 2016 - (Recall #: Z-0682-2016)

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:

Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy 1503-3006-000 Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).

Product Classification:

Class II

Date Initiated: December 15, 2015

Date Posted: January 27, 2016

Recall Number: Z-0682-2016

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: 240

Code Information:

11328664 11335735 11343334 11343892 11342401-2 5400168 5403740-1 5403740-2 11335499 11345497 11340364 11320301-1 11320301-2 11330567 11331744 11307341 11331786 11335845 11335293 11319820 11321192 11321193 11327291 11322915 11332821 11326031 11330266 11313876 11331340 11304929 11336322 11336553 11315455 11325139 11326345 11335028-1 11335028-2 11305735 11322211 11323901 6514379 6514380 11307579 11307579 11321258 5398226 5405405 11337945 5404884 5405628 5406602 5401553-1 5401553-2 5402221-1 5402221-2 5402221-3 5404056-1 5404056-2 5404550-1 5404550-2 5404550-3 5404550-4 5405413-1 5405413-2 5405413-3 5405699-1 5405699-2 5405699-3 11009279 5405867 5405868 5398018-1 5398018-2 5404050-1 5404050-2 5405504-1 5405504-2 11320017 11324236 11311155 11342043 5401539 5401527-1 5401527-2 5401527-3 5401527-4 11315668 5401531 11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531 11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531

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