Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer — Class II medical device recall Z-2161-2013
Terminated recall by GE Healthcare, LLC, reported 2013-09-18, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pre
| Recall number | Z-2161-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-07-29 |
| Classified | 2013-09-06 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2015-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BO, BR, BS, CA, CH, CL, CN, CR, CY, DE, DK, EC, ES, FR, GB, GR, HK, HR, IE, IL, IN, IT, JO, KR, KW, LT, MT, MX, MY, NL, NO, NZ, OM, PK, PL, PT, QA, SA, SG, TH, TR, TW, VE, ZA |
| Reason classes | specification failure, packaging |
| Model numbers | 1107-9601-000, 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, 1107-9612-000, 1107-9614-000, 1107-9615-000, 1107-9616-000, 1107-9617-000, 2064455-001, 2064455-X, 2066725-001, 2066725-X, 2066835-001, 2066835-X, 2069767-001, 2069767-X, M1098876 and 72 more |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2161-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.