FDA Device recall Z-0815-2025
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO by Ge Medical Systems, citing due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0815-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-18 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
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.
Identifiers
| code_info | GTIN: 00840682124744; Serial Numbers: SQAD01037 SQAD01038 SQAD01041 SQAC01464 SQAC01467 SQAC00988 SQAC00987 SQAD01184…GTIN: 00840682124744; Serial Numbers: SQAD01037 SQAD01038 SQAD01041 SQAC01464 SQAC01467 SQAC00988 SQAC00987 SQAD01184 SQAD01219 SQAD01221 SQAD01222 SQAC01106 SQAD00048 SQAD00057 SQAD00059 SQAD00116 SQAD00124 SQAD00127 SQAD00129 SQAD00134 SQAD00136 SQAD00137 SQAD00139 SQAD00144 SQAD00576 SQAD00577 SQAD00581 SQAC00844 SQAC00851 SQAC00852 SQAC00854 SQAC00855 SQAC00856 SQAC00857 SQAC00858 SQAC00930 SQAC00842 SQAC00895 SQAC00517 SQAC01192 SQAD00860 SQAC01203 SQAC00989 SQAC00990 SQAC01186 SQAD00142 SQAD00486 SQAD00498 SQAD00831 SQAD00853 SQAD00855 SQAD00856 SQAD00857 SQAD00862 SQAD00863 SQAD00871 SQAD00873 SQAD00881 SQAD00883 SQAD00887 SQAD01109 SQAD01117 SQAD01168 SQAD00704 SQAD00736 SQAD00720 SQAD00747 SQAD00754 SQAD00761 SQAD00784 SQAD01031 SQAD01033 SQAD00523 SQAD00527 SQAD00583 SQAC01468 SQAD00140 SQAD00143 SQAD00808 SQAC01367 SQAC01389 SQAC01397 SQAC01190 SQAD00870 SQAD00859 SQAC01424 SQAC00881 SQAC01457 SQAC01476 SQAC01494 SQAC01445 SQAC01373 SQAC01435 SQAC01447 SQAC01361 SQAD00202 S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0815-2025%22
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