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.
Enforcement
- Recall Number
- Z-2161-2013
- Event ID
- 65970
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Healthcare, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 18, 2013
- Initiation Date
- July 29, 2013
- Classification Date
- September 6, 2013
- Termination Date
- April 17, 2015
- Address
- 3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States
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.
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
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
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,
31,443 devices (23,947 US, 7496 OUS)