Z-1198-2018 Class II Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
October 4, 2017
Termination Date
April 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28

Product Description

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.

Reason for Recall

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

Distribution Pattern

US Distribution to states of: AZ, IL NC, NH and PA.

Code Information

Model # M1107626 Mfg. Lot or Serial #: BEJN05568, BEJM03853, BEJM04539, BEJN05793, BEJP01947, BEJP03924, BEJP04380, BEJP08533, BEJU06631, BEJN06095, BEJP04706, BEJU05053, BEJM04542, BEJM04881, BEJM04901, BEJN07748, BEJN07849, BEJP03230, BEJP03239, BEJP03559, BEJP03984, BEJP05309, BEJP05347, BEJP05825, BEJP05834, BEJP05978, BEJP08567, and BEJP09304.