FDA recall Z-0814-2025

GE Medical Systems, LLC · Class II · device

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, M1221495, and M1233992

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-0814-2025