Recall Z-0816-2025 ยท CAD Vaporizer, Anesthesia, Non-Heated
GE Medical Systems, LLC
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
| Date | Jan 7, 2025 (initiated Nov 18, 2024) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 11/18/24 was sent to customers. Actions to be taken by Customer/User You can continue to use the vaporizer in accordance with the instructions in the User Reference Manual (URM) and the actions described below: 1. Perform the Output Concentration Check described in Appendix 1 for every impacted vaporizer (see Affected Product Details in this letter). " If a vaporizer passes the Output Concentration Check, you can continue to use that vaporizer. GE HealthCare recommends use of anesthetic agent monitoring during vaporizer use. " If a |
| Quantity | 928 units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172702 | Tec 820, Tec 850 Datex-Ohmeda, Inc., Jan 4, 2018 |