Vaporizer, Anesthesia, Non-heated
Anesthesiology · 21 CFR 868.5880
Recent MDR events
4,534 adverse event reports on file
- TEC 6 PLUSJul 29, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04758
- TECJul 29, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04760
- Vapor 19.3Jul 29, 2026InjuryDrägerwerk Ag & Co. Kgaa9611500-2026-00389
- Tec 6 PlusJul 29, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04769
- TECJul 28, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04743
- TEC 6 PLUSJul 27, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04723
- TECJul 20, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04575
- TEC 6 PLUSJul 17, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04522
- TEC 7Jul 17, 2026MalfunctionDatex-ohmeda, Inc.2112667-2026-04526
- VAPOR 2000Jul 16, 2026InjuryDrägerwerk Ag & Co. Kgaa9611500-2026-00376
Event type breakdown
Recalls
13 recall events for this product code
- Draeger, Inc.Open, ClassifiedDec 23, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
Z-0933-2026 · View FDA record ↗ - Draeger, Inc.Open, ClassifiedDec 23, 2025
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
Z-0934-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedJan 7, 2025
Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Z-0814-2025 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedJan 7, 2025
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Z-0815-2025 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedJan 7, 2025
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Z-0816-2025 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedJan 7, 2025
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Z-0817-2025 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedJan 7, 2025
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Z-0818-2025 · View FDA record ↗ - Penlon, Ltd.TerminatedJul 2, 2013
Delta Vaporizer
It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.
Z-1653-2013 · View FDA record ↗ - Datex - Ohmeda, IncTerminatedNov 21, 2006
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.
There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.
Z-0201-2007 · View FDA record ↗ - Southmedic IncTerminatedJul 4, 2006
Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from
Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.
Z-1189-06 · View FDA record ↗
Registered firms
31 firms currently registered for this product code
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Penlon Ltd.
ABINGDON Oxfordshire, GB
Automatics Tooling Company Ltd
Salfords Surrey, GB
Shenzhen Mindray Bio-medical Electronics Co.,ltd
SHENZHEN Guangdong, CN
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Spacelabs Healthcare Ltd.
HERTFORD Hertfordshire, GB
Datex-ohmeda, Inc.
MADISON, WI, US
Draeger Interservices Gmbh
Luebeck Schleswig-Holstein, DE
Worldwide Supplies Limited
Hong Kong, HK
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
510(k) clearances
57 clearances for this product code
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Oct 31, 2024
K240375 · V80 Anesthetic Vaporizer (V80)
- Datex-Ohmeda, Inc.Jan 4, 2018
K172702 · Tec 820, Tec 850
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Jun 30, 2015
K150167 · V60 Anesthetic Vaporizer
- Piramal Critcal Care, Inc (Formerly Minrad, Inc)Jul 20, 2011
K110608 · SEVOFLURANE VAPORIZER ADAPTOR
- Penlon LimitedMay 10, 2006
K060331 · SIGMA ALPHA VAPORIZER
- Penlon LimitedMar 3, 2006
K053564 · KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
- General Anaesthetic Services LimitedAug 23, 2005
K051666 · GAV - GENERAL ANAESTHETIC VAPORIZER
- Draeger Medical, Inc.Sep 23, 2004
K042276 · D-VAPOR