Medical device recalls Moderate risk

GE Medical Systems, LLC recalls Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO

Recall date
November 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0815-2025
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 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO

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