FDA-Device2025-01-15Class II

Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV

GE Medical Systems, LLC
Hazard

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

Sold states
US Nationwide. Global Distribution.
Affected count
928 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0816-2025

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