Medical device recalls Moderate risk

GE Medical Systems, LLC recalls Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-961…

Recall date
November 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0814-2025
FDA classification
Class II
Brand / firm
GE Medical Systems, LLC
Sold / distributed
US Nationwide. Global Distribution.

Why it was recalled

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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, M1221495, and M1233992

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