The Recall Desk
ModerateFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · nonconforming device

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