GE Healthcare, LLC: Medical Device Recall in 2013 - (Recall #: Z-2161-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.

Product Classification:

Class II

Date Initiated: July 29, 2013

Date Posted: September 18, 2013

Recall Number: Z-2161-2013

Event ID: 65970

Reason for Recall:

GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to

Status: Terminated

Product Quantity: 31,443 devices (23,947 US, 7496 OUS)

Code Information:

Part Numbers: X1107-9001-000, X1107-9002-000, X1107-9003-000, X1107-9004-000, X1107-9005-000, X1107-9006-000, X1107-9007-000, X1109-9008-000, X1109-9009-000, X1107-9010-000, X1107-9011-000, X1107-9012-000, X1107-9014-000, X1107-9015-000, X1107-9016-000, X1107-9101-000, X1107-9102-000, X1107-9103-000, X1107-9201-000, X1107-9202-000, X1107-9203-000, X1107-9205-000, X1107-9206-000, X1107-9601-000, X1107-9602-000, X1107-9603-000, X1107-9604-000, X1107-9605-000, X1107-9606-000, X1107-9607-000, X1107-9608-000, X1107-9609-000, X1107-9610-000, X1107-9611-000, X1107-9612-000, X1107-9614-000, X1107-9615-000, X1107-9616-000, X1107-9617-000, M1145610-X, M1220023-X, M1220854-X, M1221495-X, 2064455-X, M1243207-X, X1107-9701-000, X1107-9702-000, X1107-9703-000, X1107-9211-000, X1107-9212-000, X1107-9213-000, X1107-9215-000, X1107-9216-000, X1107-9217-000, X1107-9207-000, X1107-9208-000, 2066725-X, 2066835-X, 2069767-X, 1107-9601-000, 1107-9612-000, M1221495, M1220023, M1243207, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9605-000, 1107-9606-000, 1107-9607-000, 1107-9608-000, 1107-9609-000, 1107-9610-000, 1107-9611-000, 1107-9614-000, 1107-9615-000, 1107-9616-000, 1107-9617-000, M1145610, M1220854, 2064455-001, M1098876, 2066725-001, 2066835-001, 2069767-001, X1107-8003-000, X1107-8006-000, X1107-8007-000, X1107-8008-000, X1107-8012-000, X1107-8013-000, X1107-8014-000, X1107-8015-000, X1107-8016-000, X1107-8017-000, X1107-8018-000, X1107-8019-000

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA local name-Hrvatska, CYPRUS, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA-REPUBLIC OF, KUWAIT, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA,

Voluntary or Mandated:

Voluntary: Firm initiated