GE Medical Systems, LLC recalls Tec 850 ISO Anesthesia Vaporizer
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Lot / code information
- GTIN
- 00840682124751
- Serial #
SQAC00742 SQAC00743 SQAC00749 SQAC01478 SQAC01480 SQAC01482 SQAC01483 SQAC01484 SQAC01485 SQAC01486 SQAC01100 SQAD01228 SQAC00649 SQAD00303 SQAD01180 SQAD01191 SQAD00165 SQAD00170 SQAC00944 SQAD00135…Show all
SQAC00742 SQAC00743 SQAC00749 SQAC01478 SQAC01480 SQAC01482 SQAC01483 SQAC01484 SQAC01485 SQAC01486 SQAC01100 SQAD01228 SQAC00649 SQAD00303 SQAD01180 SQAD01191 SQAD00165 SQAD00170 SQAC00944 SQAD00135 SQAD00148 SQAD01165 SQAC01012 SQAC01014 SQAD00107 SQAD00758 SQAD00767 SQAD00790 SQAC01172 SQAC00827 SQAC00835 SQAD00497 SQAC01111 SQAC01160 SQAC01180 SQAC01182 SQAC01183 SQAC00902 SQAC00904 SQAD00674 SQAD00677 SQAC00976 SQAD01129 SQAD01143 SQAD00045 SQAD00047 SQAD00181 SQAD00187 SQAC01376 SQAC01379 SQAC00666 SQAC00668 SQAC01019 SQAD00161 SQAD00168 SQAD00169 SQAD00178 SQAD00179 SQAC00908 SQAC00584 SQAC00876 SQAC00841 SQAD01178 SQAC00789 SQAD00120 SQAD00141 SQAD00482 SQAD00517 SQAD00519 SQAD00520 SQAD00521 SQAD00522 SQAD00530 SQAD00864 SQAD00866 SQAD00868 SQAD00869 SQAD00872 SQAD00874 SQAD00877 SQAD00878 SQAD00890 SQAD00891 SQAD00892 SQAD00895 SQAD00896 SQAD00897 SQAD00899 SQAD00905 SQAC01007 SQAD00787 SQAD00793 SQAD00810 SQAD00814 SQAC00967 SQAC00968 SQAC00971 SQAC00972 SQAC00662 SQAC00763 SQAC00688 SQAC00665 SQAC00759 SQAC01008 SQAC01371 SQAC01402 SQAD01171 SQAD01172 SQAD01179 SQAD01150 SQAD01158 SQAD01163 SQAC00973 SQAC00978 SQAD01067 SQAC01001 SQAD00722 SQAD00723 SQAD00725 SQAD00726 SQAD00727 SQAD00728 SQAD00729 SQAD00731 SQAD00733 SQAD00739 SQAC01363 SQAC01370 SQAC00708 SQAC01372 SQAD00902 SQAC00899 SQAC00905 SQAD00765 SQAD00766 SQAD00769 SQAD00771 SQAD00772 SQAD00773 SQAD00774 SQAD00776 SQAD00782 SQAC00999 SQAC01000 SQAC01003 SQAC01004 SQAC01017 SQAD00356 SQAC01383 SQAC00524 SQAC00986 SQAC01463 SQAC00698 SQAC01410 SQAD00249 SQAD00385 SQAC00639 SQAD00745 SQAD00954 SQAC00777 SQAD00732 SQAD00804 SQAD00806 SQAD00807 SQAD00809 SQAC01251 SQAC01322 SQAD00248 SQAD00250 SQAD00252 SQAD00254 SQAD00257 SQAD00312 SQAD00313 SQAD00315 SQAD00054 SQAD00055 SQAD00183 SQAD00185 SQAD00239 SQAD00241 SQAD00688 SQAD00186 SQAD00194 SQAC01236 SQAC00657 SQAC00781 SQAC00782 SQAC00783 SQAC00784 SQAC00788 SQAC00792 SQAD00652 SQAD00130 SQAC01431 SQAD01229 SQAD01235 SQAD01237 SQAD01239 SQAD00227 SQAD00230 SQAD00235 SQAD00236 SQAD01164 SQAC01413 SQAC01416 SQAC01425 SQAC00588 SQAC00602 SQAC00640 SQAC00677 SQAC00680 SQAC00683 SQAC00689 SQAC00699 SQAD00095 SQAC01235 SQAC01264 SQAD00792 SQAD00797 SQAD00504 SQAD00701 SQAD00818 SQAD01169 SQAD00691 SQAC00570 SQAC00572 SQAC00575 SQAD01176 SQAC01168 SQAC01011 SQAC01028 SQAC01029 SQAD00222 SQAD00242 SQAD00243 SQAD00244 SQAD00245 SQAD00299 SQAD00300 SQAD00301 SQAD00304 SQAD00306 SQAC01036 SQAC01041 SQAC01042 SQAC00667 SQAC00669 SQAC00670 SQAC00671 SQAC00762 SQAC01162 SQAC00635 SQAC00638 SQAC00748 SQAD00956 SQAC00878 SQAC00809 SQAC00810 SQAC00845 SQAC00896 SQAD01065 SQAD00805 SQAD00811 SQAC01156 SQAD00177 SQAD00180 SQAD00182 SQAD00963 SQAD00921 SQAD00922 SQAD00514 SQAD00560 SQAD00562 SQAC01242 SQAD00028 SQAD00033 SQAD00034 SQAD00035 SQAD00038 SQAD00039 SQAC01167 SQAC01252 SQAC01254 SQAC01255 SQAC01257 SQAD00311 SQAD00867 SQAD00875 SQAD00876 SQAD00879 SQAD00880 SQAD01100 SQAD01101 SQAD01108 SQAD01120 SQAD01177 SQAD01181 SQAC00663 SQAD00081 SQAD00082 SQAD00083 SQAD00084 SQAD00085 SQAD00086 SQAD00908 SQAD00931 SQAD00934 SQAD00171 SQAC00824 SQAD00069 SQAD00911 SQAD00903 SQAD00933 SQAD01230 SQAC01053 SQAC01065 SQAC01074 SQAC01082 SQAC01083 SQAC01087 SQAC01088 SQAC01090 SQAC01091 SQAC01092 SQAC01093 SQAD00696 SQAD00698 SQAC01209 SQAC01002 SQAD00046 SQAD00050 SQAD00052 SQAD00056 SQAD00707 SQAD00716 SQAD00719 SQAD00788 SQAD00708 SQAD00711 SQAD00712 SQAD00715 SQAD00803 SQAD01170 SQAD00799 SQAD00802 SQAC00775 SQAC00776 SQAC00522 SQAC00952 SQAD00328 SQAC00836 SQAC00887 SQAC00913 SQAC00914 SQAC00917 SQAC00919 SQAC00920 SQAC00921 SQAC00923 SQAC00924 SQAC00925 SQAC00974 SQAC01391 SQAC01396 SQAC00802 SQAC01109 SQAC01176 SQAC01177 SQAC00648 SQAC00652 SQAC00969 SQAC00980 SQAC00981 SQAC00982 SQAC00983 SQAC01193 SQAC01225 SQAC01374 SQAC01184 SQAC01185 SQAC01197 SQAC00975 SQAC01039 SQAD01167 SQAD00542 SQAD00548 SQAD00551 SQAD00555 SQAD00557 SQAD00559 SQAD00561 SQAD00764 SQAC01159 SQAC01179 SQAC01095 SQAD01236 SQAC00823 SQAC00825 SQAC00826 SQAC00828 SQAD00106 SQAD01217 SQAD00302 SQAC01084 SQAC01086 SQAC01097 SQAC00500 SQAD00724 SQAD00760 SQAD00763 SQAD00768 SQAD01131 SQAD00307 SQAC01206 SQAC01067 SQAC01077 SQAC01381 SQAC00521 SQAC00512 SQAD00693 SQAD00694 SQAD00695 SQAD00697 SQAC00501 SQAC00673 SQAC00697 SQAC00916 SQAC01355 SQAC01365 SQAD00689 SQAC01098 SQAC00883 SQAC01094 SQAC01452 SQAC01454 SQAC01472 SQAC01473 SQAC01475 SQAC01479 SQAC01481 SQAD01173 SQAD01160 SQAD01187 SQAD01189 SQAD01190 SQAD00702 SQAD00703 SQAC00502 SQAC00503 SQAC00505 SQAC00506 SQAD00985 SQAC00744 SQAC00576 SQAC00922 SQAC01267 SQAD00647 SQAD00990 SQAD00992 SQAD00997 SQAD01003 SQAD00354 SQAD00525 SQAD00526 SQAD00552 SQAC00794 SQAC00797 SQAC00798 SQAC00799 SQAC00801 SQAC00803 SQAC00805 SQAC00806 SQAC00807 SQAC00808 SQAD00937 SQAD00938 SQAD00941 SQAD00943 SQAD00944 SQAC00804 SQAC01018 SQAC01196 SQAC01005 SQAC01006 SQAD00851 SQAD00861 SQAD00882 SQAC01263 SQAC01265 SQAC01271 SQAC01272 SQAC01273 SQAC00494 SQAC00834 SQAC01030 SQAD00340 SQAD00344 SQAD00345 SQAD00348 SQAD00349 SQAD00546 SQAD00549 SQAD00553 SQAD00554 SQAD00567 SQAD00568 SQAD00571 SQAD00572 SQAD00578 SQAD00580 SQAD00624 SQAD00627 SQAD00630 SQAD00636 SQAD00638 SQAD00639 SQAD00641 SQAD00643 SQAD00646 SQAC00562 SQAC00573 SQAC00574 SQAC00817 SQAC00818 SQAC01221 SQAD00232 SQAD00233 SQAD00238 SQAD00812 SQAD00295 SQAD00297 SQAD00298 SQAD00308 SQAD00314 SQAC00897 SQAC00569 SQAC01166 SQAD00005 SQAC00495 SQAD00949 SQAC00903 SQAD00953 SQAD00909 SQAD00951 SQAC00839 SQAC00707 SQAD00346 SQAD00730 SQAD00734 SQAD00735 SQAD00737 SQAD00738 SQAC00596 SQAC00597 SQAC00598 SQAC00606 SQAC00628 SQAC00636 SQAC00561 SQAC00595 SQAC00583 SQAC00627 SQAC00560 SQAC00590 SQAC00599 SQAC00611 SQAC00613 SQAC00616 SQAC00617 SQAC00618 SQAC00620 SQAC00621 SQAC00623 SQAC00624 SQAC00625 SQAC00626 SQAC00630 SQAD00029 SQAD00037 SQAD00040 SQAD00041 SQAD00042 SQAD00043 SQAD00044 SQAD00049 SQAD00051 SQAD00053 SQAD00058 SQAD00060 SQAD00062 SQAD00063 SQAD00064 SQAD00067 SQAD00068 SQAD00072 SQAD00073 SQAD00074 SQAD00075 …
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide. Global Distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0817-2025
- FDA 510(k) clearance · K172702The device's official FDA premarket clearance record
- FDA device classification · CADOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5880The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find GE Medical Systems, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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