FDA Device recall Z-2161-2013
Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer by Ge Healthcare, citing 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 Vapori….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2161-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-29 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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.
Reason
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
Identifiers
| code_info | Part Numbers: X1107-9001-000, X1107-9002-000, X1107-9003-000, X1107-9004-000, X1107-9005-000, X1107-9006-000, X1107-90…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, 1107-9 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2161-2013%22
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