Recall Z-0816-2025— GE Medical Systems, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2024-11-18. It names one FDA 510(k) clearance: K172702. Product: Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV. 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..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-18
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.