Agency classClass IIOur severity:High FDA (Devices)·Z-2161-2013·Announced 2013-09-18

GE Healthcare Recalls Tec 6 Anesthesia Vaporizers Due to Leak Detection Issue

GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).

Plain-English summary

GE Healthcare, LLC is recalling the Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The recall involves 31,443 devices distributed worldwide, including 23,947 units in the United States and 7,496 units internationally. These electronic vaporizers are used to deliver the anesthetic agent desflurane and attach to specific Datex-Ohmeda and NAD anesthesia machines.

The recall was initiated because the pre-operative check, specifically the low pressure leak test at the 1% dial setting, may not detect the full range of leaks resulting from seal wear degradation in the vaporizers. If a leak is not detected during this test, it will result in fresh gas leaking from the device.

The source text does not specify the corrective actions consumers or healthcare providers should take, nor does it report any specific illnesses or injuries associated with this defect.

The recalled product

Product: Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Anesthesia Vaporizer
Hazard: leak
device-malfunction

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)

Part Numbers: X1107-9001-000
X1107-9002-000
X1107-9003-000
X1107-9004-000
X1107-9005-000
X1107-9006-000
X1107-9007-000
X1109-9008-000
X1109-9009-000
X1107-9010-000
X1107-9011-000
X1107-9012-000
X1107-9014-000
X1107-9015-000
X1107-9016-000
X1107-9101-000
X1107-9102-000
X1107-9103-000
X1107-9201-000
X1107-9202-000

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · GE Healthcare, LLC

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