Recall Z-0818-2025
GE Medical Systems, LLC · initiated November 18, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Codes / lots: GTIN: 00840682124737; Serial Numbers: SQBC03462 SQBD02949 SQBD00338 SQBC03366 SQBC03815 SQBC05612 SQBC05620 SQBC05627 SQBC05635 SQBC05637 SQBC05641 SQBC05642 SQBC03558 SQBD03089 SQBD04439 SQBD04457 SQBD04459 SQBD04468 SQBD04702 SQBC04948 SQBC05702 SQBD02556 SQBC03896 SQBC04666 SQBC03225 SQBD02978 SQBD01384 SQBC02115 SQBC02023 SQBD04606 SQBD01484 SQBD04811 SQBC03549 SQBC03554 SQBC03559 SQBC03888 SQBC03970 SQBC04507 SQBD00211 SQBC02666 SQBC02959 SQBD00220 SQBD00402 SQBC01921 SQBC02087 SQBC02330 SQBC03003 SQBC01843 SQBC01855 SQBC04513 SQBD00326 SQBC05544 SQBC01450 SQBC02011 SQBC04529 SQBD01491 SQBD04711 SQBC01581 SQBC01747 SQBC02108 SQBC02162 SQBC02165 SQBC02183 SQBC02595 SQBC03023 SQBC05440 SQBD00444 SQBD00581 SQBC02204 SQBC02837 SQBD02999 SQBC01275 SQBC01279 SQBC01280 SQBC01283 SQBC01286 SQBC03723 SQBC02951 SQBD03058 SQBC03476 SQBD01380 SQBC03932 SQBC03969 SQBD04515 SQBD01481 SQBD01489 SQBD01315 SQBC01923 SQBD04013 SQBD04032 SQBD04034 SQBD04292 SQBD04307 SQBC02190 SQBC01912 SQBC05459 SQBD02862 SQBD02869 SQBD02886 SQBC02729 SQBC02747 SQBC01321 SQBC01322 SQBC01333 SQBD00159 SQBD02160 SQBC04115 SQBD02228 SQBD02276 SQBC02688 SQBC02753 SQBC02902 SQBD04016 SQBC01702 SQBC01811 SQBC01857…
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.
FDA-determined cause: Process control
Action taken
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 vaporizer fails the Output Concentration Check, you can continue to use that vaporizer with anesthetic agent monitoring until GE HealthCare corrects the vaporizer. " If a vaporizer fails the Output Concentration Check and anesthetic agent monitoring is not available, remove the vaporizer from service. 2. Please complete and return the attached Medical Device Notification Acknowledgement Response Form to ARC.FMI34139@gehealthcare.com 3. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions. 4. Please retain this document for your records. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-0818-2025
- Initiated
- November 18, 2024
- Posted by FDA
- January 7, 2025
- Product code
- CAD – Vaporizer, Anesthesia, Non-Heated
- Quantity
- 8319 units
- Distribution
- US Nationwide. Global Distribution.
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0814-2025 Class II | Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000…Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | 11/18/2024Open, Classified |
| Z-0815-2025 Class II | Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISODue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | 11/18/2024Open, Classified |
| Z-0816-2025 Class II | Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEVDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | 11/18/2024Open, Classified |
| Z-0817-2025 Class II | Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISODue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | 11/18/2024Open, Classified |