Class 2 Device Recall Tec 820 SEV

• Date Initiated by Firm: November 18, 2024
• Date Posted: January 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0816-2025
• Recall Event ID: 95855
• 510(K)Number: K172702
• Product Classification: Vaporizer, anesthesia, non-heated - Product Code CAD
• Product: Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
• Code Information: 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 SQBC05649 SQBC05756 SQBD00074 SQBD00075 SQBD00085 SQBD00088 SQBD00097 SQBC04884 SQBC04891 SQBC04911 SQBC04912 SQBC04915 SQBD00018 SQBC05280 SQBC04610 SQBC03586 SQBC03793 SQBC04164 SQBC04886 SQBC04908 SQBC04909 SQBC04910 SQBC04913 SQBC05032 SQBC00553 SQBC01661 SQBC01671 SQBC01672 SQBC01673 SQBC01681 SQBC01690 SQBC01698 SQBC01712 SQBC01716 SQBC01724 SQBC01742 SQBC01758 SQBC02626 SQBC02661 SQBC04044 SQBC04054 SQBC04085 SQBC04086 SQBC04157 SQBC04863 SQBC01377 SQBC01718 SQBC02092 SQBC02370 SQBC02619 SQBC02624 SQBC02645 SQBC02651 SQBC02657 SQBC02659 SQBC02662 SQBC04527 SQBC04614 SQBC02587 SQBC03672 SQBC03753 SQBC03830 SQBC03850 SQBC04046 SQBC04049 SQBC04052 SQBC04090 SQBC04592 SQBC04599 SQBC04601 SQBC04604 SQBC04606 SQBC04611 SQBC04615 SQBC04620 SQBC04642 SQBC01160 SQBC01163 SQBC01167 SQBC01209 SQBC01237 SQBC01367 SQBC02357 SQBC01295 SQBC01408 SQBC01669 SQBC01680 SQBC01682 SQBC01687 SQBC01693 SQBC01711 SQBC01813 SQBC01883 SQBC03039 SQBC03139 SQBC03159 SQBC03195 SQBC03196 SQBC03773 SQBC04050 SQBC04449 SQBC04581 SQBC04985 SQBC04991 SQBC05024 SQBC00566 SQBC01045 SQBC01111 SQBC01119 SQBC01156 SQBC01169 SQBC01343 SQBC01358 SQBC01372 SQBC01373 SQBC01735 SQBC01745 SQBC04978 SQBC05033 SQBC01077 SQBC01088 SQBC01129 SQBC01253 SQBC01254 SQBC01267 SQBC01331 SQBC01338 SQBC01361 SQBC01395 SQBC01652 SQBC01664 SQBC01685 SQBC01686 SQBC01692 SQBC01739 SQBC04618 SQBC01394 SQBC01845 SQBC01854 SQBC01856 SQBC01858 SQBC01859 SQBC01861 SQBC01862 SQBC01863 SQBC01900 SQBC02343 SQBC02589 SQBC02598 SQBC02631 SQBC02641 SQBC02646 SQBC02656 SQBC02658 SQBC02660 SQBC03104 SQBC03111 SQBC03143 SQBC03146 SQBC03155 SQBC03158 SQBC03160 SQBC03162 SQBC03179 SQBC03180 SQBC03197 SQBC03200 SQBC03580 SQBC03657 SQBC03752 SQBC03810 SQBC03852 SQBC03992 SQBC04027 SQBC04043 SQBC04045 SQBC04056 SQBC04058 SQBC04059 SQBC04088 SQBC04135 SQBC01409 SQBC01741 SQBC01743 SQBC01754 SQBC01755 SQBC01759 SQBC01760 SQBC03680 SQBC03947 SQBC04197 SQBC04404 SQBC04554 SQBC04577 SQBC04579 SQBC04584 SQBC04588 SQBC04589 SQBC04609 SQBC01721 SQBC01736 SQBC01737 SQBC01738 SQBC01740 SQBC01752 SQBC02116 SQBC02232 SQBC02269 SQBC02606 SQBC02642 SQBC01399 SQBC02599 SQBC02625 SQBC02639 SQBC02643 SQBC02649 SQBC02593 SQBC03583 SQBC04587 SQBC04371 SQBC04386 SQBC04578 SQBC01720 SQBC01165 SQBC01227 SQBC01266 SQBC01365 SQBC01405 SQBC02604 SQBC03581 SQBC03612 SQBC04188 SQBC04452 SQBC04598 SQBC04600 SQBC04603 SQBC04623 SQBC01636 SQBC01683 SQBC01706 SQBC01730 SQBC01753 SQBC01762 SQBC03135 SQBC03161 SQBC03734 SQBC03974 SQBC04057 SQBC04084 SQBC04173 SQBC04576 SQBC01393 SQBC01666 SQBC01675 SQBC01676 SQBC01688 SQBC01694 SQBC01700 SQBC01715 SQBC01719 SQBC01729 SQBC01732 SQBC01734 SQBC01746 SQBC01749 SQBC01750 SQBC01751 SQBC01756 SQBC01757 SQBC01761 SQBC01763 SQBC01764 SQBC01765 SQBC01767 SQBC03686 SQBC03712 SQBC04559 SQBC04597 SQBC04605 SQBC04607 SQBC05277 SQBC03667 SQBC03741 SQBC03742 SQBC03790 SQBC03823 SQBC03832 SQBC04048 SQBC04051 SQBC04055 SQBC04071 SQBC04134 SQBC04152 SQBC05131 SQBC05242 SQBC05543 SQBC04869 SQBC04308 SQBC04379 SQBC04518 SQBC04550 SQBC04575 SQBC04608 SQBC04705 SQBC04711 SQBC04786 SQBC04791 SQBC04823 SQBC04849 SQBC05198 SQBC05721 SQBD00009 SQBC05070 SQBC05129 SQBC05670 SQBC05751 SQBD00076 SQBC05191 SQBC05587 SQBD00023 SQBC05619 SQBD00021 SQBD00025 SQBD00014 SQBC05616 SQBC05003 SQBC05004 SQBC05008 SQBC05012 SQBC05090 SQBC05126 SQBC05227 SQBC05249 SQBC05091 SQBC04925 SQBD00080 SQBD00086 SQBD00087 SQBD00089 SQBD00093 SQBD00104 SQBD00105 SQBD00102 SQBC05656 SQBD00006 SQBC05006 SQBC05158 SQBD02354 SQBC05357 SQBC05361 SQBC04715 SQBD02341 SQBD04717 SQBD04725 SQBC03401 SQBC04996 SQBC05051 SQBD04140 SQBD04205 SQBD04396 SQBC05022 SQBC05045 SQBD02353 SQBC04734 SQBD03522 SQBD03542 SQBD03547 SQBD03555 SQBD03601 SQBD03624 SQBD03638 SQBD03645 SQBD03677 SQBD03698 SQBD03732 SQBD03756 SQBD03869 SQBD03876 SQBD03893 SQBD03922 SQBC05378 SQBD02561 SQBD02345 SQBC05362 SQBD02550 SQBC03425 SQBD02474 SQBC04100 SQBC04280 SQBC05343 SQBC05344 SQBC03460 SQBD02468 SQBD02493 SQBC03327 SQBD04379 SQBD04709 SQBD02490 SQBC04813 SQBC04655 SQBD00728 SQBC04808 SQBC04846 SQBC03316 SQBC03320 SQBC03426 SQBC03433 SQBC03950 SQBC04281 SQBC04807 SQBC04851 SQBC04852 SQBD00726 SQBD00729 SQBD00793 SQBD01054 SQBD01089 SQBD01110 SQBD01218 SQBC03199 SQBC03228 SQBC05570 SQBC05595 SQBC05596 SQBC05597 SQBC05598 SQBD01248 SQBD02204 SQBD02220 SQBD02351 SQBD02352 SQBD02356 SQBD02357 SQBD02358 SQBD02438 SQBD02454 SQBD02464 SQBD02469 SQBD02479 SQBD02533 SQBD02559 SQBD02560 SQBD03361 SQBD03387 SQBD03390 SQBD03660 SQBD03736 SQBD04073 SQBD04331 SQBD04516 SQBD04528 SQBD04730 SQBD04731 SQBD04742 SQBD04744 SQBD04746 SQBD04978 SQBD04983 SQBD05021 SQBD05037 SQBD05038 SQBD05040 SQBD03001 SQBD03019 SQBD03025 SQBD03043 SQBD03141 SQBD03187 SQBD03220 SQBD03224 SQBD03278 SQBD03282 SQBD03310 SQBD03312 SQBD03313 SQBD03324 SQBD03441 SQBD03575 SQBD03640 SQBD03688 SQBD03730 SQBD03731 SQBD03810 SQBD03951 SQBD03957 SQBD03968 SQBD03973 SQBD03974 SQBD03978 SQBD03983 SQBD03985 SQBC03294 SQBC05390 SQBC05523 SQBC03176 SQBC04520 SQBD03258 SQBD01244 SQBD02355 SQBC03451 SQBC05363 SQBD02360 SQBC04729 SQBD02746 SQBD02992 SQBD03222 SQBD03280 SQBD03314 SQBD03319 SQBD03338 SQBD03353 SQBD03357 SQBD03382 SQBC02128 SQBC02365 SQBD00719 SQBC05568 SQBC05548 SQBD02706 SQBD02346 SQBD02347 SQBD02348 SQBC03202 SQBD01208 SQBD01237 SQBC04732 SQBC04735 SQBC04094 SQBC04814 SQBC04845 SQBC04850 SQBC04458 SQBD04713 SQBC04854 SQBD02313 SQBC05356 SQBC05569 SQBC05573 SQBC05575 SQBC05577 SQBC05586 SQBC05593 SQBC05594 SQBD02030 SQBD00520 SQBD01090 SQBD00935 SQBC03209 SQBC03217 SQBD00931 SQBC04713 SQBC04853 SQBC05530 SQBD00876 SQBC04726 SQBC04727 SQBD01994 SQBC03194 SQBC03193 SQBC03191 SQBD02022 SQBD02036 SQBD02123 SQBD02147 SQBD02157 SQBD02161 SQBC05347 SQBC05349 SQBC05567 SQBC03174 SQBC05364 SQBD02661 SQBC05534 SQBC00930 SQBC01518 SQBC01870 SQBC01896 SQBC02106 SQBC03019 SQBC03028 SQBC03077 SQBD00668 SQBD00015 SQBD00024 SQBD00030 SQBC00901 SQBC00949 SQBC01024 SQBC01074 SQBC01516 SQBC01822 SQBC02653 SQBC02841 SQBC03377 SQBC03410 SQBC03472 SQBC03751 SQBC03860 SQBC03909 SQBC03911 SQBC04128 SQBC04349 SQBC04376 SQBC05096 SQBC05243 SQBC05342 SQBC05636 SQBD00635 SQBD00637 SQBD00651 SQBD00659 SQBD00667 SQBD01278 SQBD01343 SQBD01357 SQBD01503 SQBD02200 SQBD02427 SQBD02779 SQBD02784 SQBD01453 SQBD01501 SQBD01552 SQBD01554 SQBD01653 SQBD01658 SQBD01659 SQBD01846 SQBD01847 SQBD01848 SQBD01853 SQBD02620 SQBD02662 SQBD02693 SQBD02704 SQBD02711 SQBD02715 SQBD02745 SQBD02777 SQBD02814 SQBD02821 SQBD02829 SQBD02835 SQBD02850 SQBD02876 SQBD02882 SQBD04051 SQBD04710 SQBD04776 SQBC01684 SQBC01975 SQBC02067 SQBC02135 SQBC02158 SQBC02189 SQBC02191 SQBC02198 SQBC02218 SQBC02334 SQBC02610 SQBC02731 SQBC02780 SQBC02808 SQBC02950 SQBC02982 SQBC03101 SQBC03237 SQBC03249 SQBC03265 SQBC03302 SQBC03306 SQBC03333 SQBC03340 SQBC03364 SQBC03416 SQBC03429 SQBC03439 SQBC03442 SQBC03448 SQBC03481 SQBC03484 SQBC03485 SQBC03488 SQBC03499 SQBC03526 SQBC03529 SQBC03551 SQBC03584 SQBC03603 SQBC03629 SQBC03683 SQBC03839 SQBC03857 SQBC03913 SQBC03918 SQBC03951 SQBC04108 SQBC04130 SQBC04225 SQBC04231 SQBC04246 SQBC04276 SQBC04287 SQBC04289 SQBC04314 SQBC04334 SQBC04753 SQBC04756 SQBC04757 SQBC04761 SQBC04798 SQBC04799 SQBC04800 SQBC04834 SQBC04836 SQBC04930 SQBC04934 SQBC04937 SQBC04940 SQBC05335 SQBC05358 SQBC05359 SQBC05388 SQBC05389 SQBC05738 SQBD00044 SQBD00056 SQBD00057 SQBD00058 SQBD00059 SQBD00060 SQBD00061 SQBD00067 SQBD00069 SQBD00413 SQBD00433 SQBD00512 SQBD00513 SQBD00516 SQBD00544 SQBD00596 SQBD00608 SQBD00628 SQBD00639 SQBD01293 SQBD01447 SQBD01468 SQBD01720 SQBD01762 SQBD02471 SQBD02482 SQBD02621 SQBD02649 SQBD02653 SQBD02673 SQBD02682 SQBD02703 SQBD02707 SQBD02742 SQBD02750 SQBD02762 SQBD02764 SQBD02765 SQBD02796 SQBD02854 SQBD02866 SQBD02880 SQBD02889 SQBD02892 SQBD02900 SQBD02901 SQBD02913 SQBD02915 SQBD02916 SQBD02958 SQBC01674 SQBC01825 SQBC01907 SQBC01938 SQBC02083 SQBC02680 SQBC02819 SQBC03794 SQBC04522 SQBD02215 SQBD02681 SQBD01482 SQBD01509 SQBD01518 SQBD02364 SQBD01522 SQBD01546 SQBD01549 SQBD01560 SQBD01582 SQBC03648 SQBC03840 SQBC03878 SQBC03935 SQBD00683 SQBD00689 SQBD00709 SQBD00715 SQBC01709 SQBD02634 SQBC05402 SQBC05405 SQBC05409 SQBC05428 SQBC05516 SQBD01286 SQBD01418
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• Manufacturer 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: 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.
• Quantity in Commerce: 928 units
• Distribution: US Nationwide. Global Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAD