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[Recalled] 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 on

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductTec 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 with the proprietary Se
Brand / manufacturerGE Healthcare, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2161-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date29 July 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from GE Healthcare, LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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