FDA recall Z-0816-2025

GE Medical Systems, LLC · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide. Global Distribution.

Key facts

Status
Ongoing
Initiation date
2024-11-18
Report date
2025-01-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

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