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
X1107-9001-000X1107-9002-000X1107-9003-000X1107-9004-000X1107-9005-000X1107-9006-000X1107-9007-000X1109-9008-000X1109-9009-000X1107-9010-000X1107-9011-000X1107-9012-000X1107-9014-000X1107-9015-000X1107-9016-000X1107-9101-000X1107-9102-000X1107-9103-000X1107-9201-000X1107-9202-000X1107-9203-000X1107-9205-000X1107-9206-000X1107-9601-000X1107-9602-000X1107-9603-000X1107-9604-000X1107-9605-000X1107-9606-000X1107-9607-000X1107-9608-000X1107-9609-000X1107-9610-000X1107-9611-000X1107-9612-000X1107-9614-000X1107-9615-000X1107-9616-000X1107-9617-000M1145610-XM1220023-XM1220854-XM1221495-X2064455-XM1243207-XX1107-9701-000X1107-9702-000X1107-9703-000X1107-9211-000X1107-9212-000X1107-9213-000X1107-9215-000X1107-9216-000X1107-9217-000X1107-9207-000X1107-9208-0002066725-X2066835-X2069767-X1107-9601-000
- Part Numbers
- 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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