Medical device recalls Moderate risk

GE Healthcare, LLC recalls DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents f…

Recall date
October 4, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1198-2018
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
US Distribution to states of: AZ, IL NC, NH and PA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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