Reported Sep 18, 2013 · Terminated

Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD…

GE Healthcare, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • 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 with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.
Lot codes and dates
  • Part Numbers

    97 of 97 codes

    • 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
    • X1107-9203-000
    • X1107-9205-000
    • X1107-9206-000
    • X1107-9601-000
    • X1107-9602-000
    • X1107-9603-000
    • X1107-9604-000
    • X1107-9605-000
    • X1107-9606-000
    • X1107-9607-000
    • X1107-9608-000
    • X1107-9609-000
    • X1107-9610-000
    • X1107-9611-000
    • X1107-9612-000
    • X1107-9614-000
    • X1107-9615-000
    • X1107-9616-000
    • X1107-9617-000
    • M1145610-X
    • M1220023-X
    • M1220854-X
    • M1221495-X
    • 2064455-X
    • M1243207-X
    • X1107-9701-000
    • X1107-9702-000
    • X1107-9703-000
    • X1107-9211-000
    • X1107-9212-000
    • X1107-9213-000
    • X1107-9215-000
    • X1107-9216-000
    • X1107-9217-000
    • X1107-9207-000
    • X1107-9208-000
    • 2066725-X
    • 2066835-X
    • 2069767-X
    • 1107-9601-000
Amount recalled
31,443 devices (23,947 US, 7496 OUS)

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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 product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 17, 2015 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.