Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1198-2018·Announced 2018-04-04

GE Healthcare Recalls 28 Datex-Ohmeda TEC 7 Anesthesia Vaporizers

GE Healthcare is recalling 28 Datex-Ohmeda TEC 7 anesthesia vaporizers shipped from a service center without proper evaluation, potentially making them nonconforming.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a quality control issue (shipping without evaluation) without reporting any specific injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for voluntary precautionary recalls or low-risk contamination where harm has not been reported.

Plain-English summary

GE Healthcare, LLC is recalling 28 units of the Datex-Ohmeda TEC 7 Anesthesia Vaporizer. These devices are designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

The recall was initiated because the non-conforming devices were shipped from a service center without proper evaluation. As a result, the devices may be nonconforming. The affected units were distributed in the United States to the states of Arizona, Illinois, North Carolina, New Hampshire, and Pennsylvania.

Healthcare facilities and users should identify any affected units by checking the model number M1107626 and the specific manufacturing lot or serial numbers listed in the recall notice. Users should stop using the affected devices and contact GE Healthcare for further instructions on repair or replacement.

The recalled product

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.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Anesthesia Equipment
Hazard: nonconforming-device
Affected units: 28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · GE Healthcare, LLC

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