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D-Vapor 3000

Drägerwerk AG & Co. KGaA · Model M36700 · UDI-DI 04048675301370

CAD
1
510(k) clearances
4,533
Adverse events (2 deaths)
13
Recalls
13
Facilities

Recalls

DateFirmReason
2025-11-24Draeger, Inc.A certain component of affected devices was not delivered within specification and contained impurities.
2025-11-24Draeger, Inc.A certain component of affected devices was not delivered within specification and contained impurities.
2024-11-18GE Medical Systems, LLCDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
2024-11-18GE Medical Systems, LLCDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
2024-11-18GE Medical Systems, LLCDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
2024-11-18GE Medical Systems, LLCDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
2024-11-18GE Medical Systems, LLCDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
2017-10-04GE Healthcare, LLCNon-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
2016-04-21Draeger Medical, Inc.Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. I
2013-05-14Penlon, Ltd.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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.