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Recall Observatory FDA recall evidence

Device product

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.

Z-1198-2018

October 04, 2017

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 79493
Status
Terminated
Classification
Class II
Quantity
28
Official record key
device-enforcement:Z-1198-2018

Official wording

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

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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