Recall Z-0816-2025
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 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Codes / lots: GTIN: 00840682124720; Serial Numbers: SQBC04329 SQBD02691 SQBD02759 SQBD03566 SQBD03635 SQBD03805 SQBD04084 SQBD04327 SQBD04374 SQBD04623 SQBD00017 SQBD00156 SQBD00219 SQBD00327 SQBD00356 SQBD00357 SQBD00366 SQBD01512 SQBD01626 SQBD01733 SQBC02274 SQBC02744 SQBC02888 SQBC02893 SQBC02904 SQBC02961 SQBC02965 SQBC02968 SQBC02963 SQBC02964 SQBC00922 SQBC03323 SQBC03324 SQBC03329 SQBD02266 SQBD02395 SQBD02631 SQBD02768 SQBD03913 SQBD03925 SQBD01924 SQBD01927 SQBD01931 SQBD00407 SQBD00408 SQBD00417 SQBD00430 SQBC03018 SQBC03827 SQBD00077 SQBC05092 SQBC05653 SQBC00596 SQBC02583 SQBC02603 SQBC02605 SQBC02632 SQBC02633 SQBC04136 SQBC04180 SQBC04970 SQBC04984 SQBC04987 SQBC04994 SQBC05000 SQBC05002 SQBC05007 SQBC05009 SQBC05010 SQBC05011 SQBC05014 SQBC05023 SQBC05026 SQBC05028 SQBC01689 SQBC02597 SQBD00002 SQBD00082 SQBD00019 SQBD00010 SQBD00027 SQBC03600 SQBC03948 SQBC04612 SQBC05584 SQBC04999 SQBC05104 SQBC05251 SQBC05106 SQBC05176 SQBC05204 SQBC05303 SQBD00003 SQBC05315 SQBD00012 SQBD00071 SQBD00073 SQBD00079 SQBD00083 SQBD00096 SQBD00103 SQBD00106 SQBC05785 SQBC05806 SQBD00013 SQBC05645 SQBD00011 SQBC05690 SQBC05650 SQBC05752 SQBC05027 SQBC05030 SQBC02600 SQBC04950 SQBC04986 SQBC05025…
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-0816-2025
- Initiated
- November 18, 2024
- Posted by FDA
- January 7, 2025
- Product code
- CAD – Vaporizer, Anesthesia, Non-Heated
- Quantity
- 928 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-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 |
| Z-0818-2025 Class II | Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEVDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | 11/18/2024Open, Classified |