FDA-Device2018-04-04Class II

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

GE Healthcare, LLC
Hazard

Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Sold states
US Distribution to states of: AZ, IL NC, NH and PA.
Affected count
28
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1198-2018

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