Anesthesia Vaporizers May Deliver Less Anesthetic Than Dial Setting Due to Manufacturing Defect
Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.
What this means for you
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: FDA Class II medical device recall with no reported injuries or deaths. The hazard—under-delivery of anesthetic—poses a real risk to patient safety but no harm has been reported, meeting the rubric criterion for risk-of-harm products without reported injuries.
Plain-English summary
Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers, manufactured by GE Medical Systems, LLC, are subject to recall. Due to a manufacturing issue, these vaporizers may deliver a lower concentration of anesthetic agent than the setting indicated on the vaporizer dial.
Approximately 1,573 units are affected by this recall, distributed in the United States and globally. When a vaporizer delivers less anesthetic than the dial setting, the actual anesthetic concentration delivered to the patient differs from what the operator intended.
The recalled product
- Product
- Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M122
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- anesthetic-under-delivery
- dosing-error
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)
- REF 1107-9601-000
- GTIN 0084068211253
- REF 1107-9602-000
- GTIN 00840682112659
- REF 1107-9603-000
- GTIN 00840682112574
- REF 1107-9604-000
- GTIN 00840682112925
- REF 1107-9610-000
- GTIN 00840682112864
- REF 1107-9612-000
- GTIN 00840682113236
- REF 1107-9616-000
- GTIN 00840682113069
- REF 1107-9617-000
- GTIN 00840682112666
- REF 2066835-001
- GTIN 00840682112857
- REF 2069767-001
- GTIN 00840682112505
Distribution
Distributed nationwide across the United States.
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