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U.S. Department of Health and Human Services

Class 2 Device Recall Tec 820 ISO

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 Class 2 Device Recall Tec 820 ISOsee related information
Date Initiated by FirmNovember 18, 2024
Date PostedJanuary 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0815-2025
Recall Event ID 95855
510(K)NumberK172702 
Product Classification Vaporizer, anesthesia, non-heated - Product Code CAD
ProductTec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Code Information 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 SQAC00941 SQAD00438 SQAD00439 SQAD00441 SQAC00811 SQAC01451 SQAD00024 SQAC00953 SQAD00200 SQAD00201 SQAD00199 SQAD00412 SQAD00413 SQAD00414 SQAD00416 SQAD00417 SQAD00419 SQAD00420 SQAD00421 SQAD00422 SQAD00423 SQAD00424 SQAD00425 SQAD00427 SQAD00428 SQAD00429 SQAD00430 SQAD00431 SQAD00433 SQAD00434 SQAD00435 SQAD00198 SQAC01507 SQAD00017 SQAD00031 SQAD00189 SQAD00220 SQAC01503 SQAC01508 SQAC01453 SQAC01461 SQAD00203 SQAC01220 SQAC01224 SQAC01215 SQAC01232 SQAC01233 SQAC01237 SQAC01458 SQAC01281 SQAC00814 SQAD00844 SQAC01056 SQAC00938 SQAD00008 SQAD00016 SQAD00437 SQAD00832 SQAC01217 SQAC01223 SQAC01228 SQAC00927 SQAC01142 SQAC01143 SQAC01239 SQAC01462 SQAC00875 SQAC01032 SQAC01033 SQAC01046 SQAC01050 SQAC01052 SQAC01054 SQAC01055 SQAC01058 SQAC01060 SQAC01061 SQAC01063 SQAC01064 SQAC01066 SQAC01070 SQAC01071 SQAC01072 SQAC01214 SQAC01226 SQAC01227 SQAC01229 SQAC01238 SQAC01245 SQAC01248 SQAC01249 SQAC01259 SQAC01276 SQAC01277 SQAC01279 SQAC01282 SQAC01285 SQAC01466 SQAC01500 SQAD00375 SQAD00377 SQAD00379 SQAD00380 SQAD00382 SQAD00383 SQAD00386 SQAD00387 SQAD00389 SQAC01470 SQAC01474 SQAD00032 SQAD00228 SQAD00234 SQAD00404 SQAD00426 SQAD00432 SQAD00436 SQAD00447 SQAD00450 SQAD00451 SQAD00452 SQAD00455 SQAD00456 SQAD00457 SQAD00458 SQAD00459 SQAD00460 SQAD00461 SQAD00462 SQAD00463 SQAD00464 SQAD00466 SQAD00467 SQAD00468 SQAD00469 SQAD00471 SQAD00740 SQAD00813 SQAD00828 SQAD00829 SQAD00830 SQAD00833 SQAD00834 SQAD00835 SQAD00836 SQAD00837 SQAD00838 SQAD00839 SQAD00840 SQAD00842 SQAD00843 SQAD00846 SQAD00847 SQAD00889 SQAD01016 SQAD01018 SQAD01030 SQAD01039 SQAD01043 SQAD01044 SQAD01045 SQAD01046 SQAD01047 SQAD01048 SQAD01051 SQAD01053 SQAD01054 SQAD01055 SQAD01060 SQAD01061 SQAD01062 SQAD01063 SQAD01064 SQAD01110 SQAD01111 SQAD01112 SQAD01113 SQAD01114 SQAD01115 SQAD01116 SQAD01118 SQAD01119 SQAD01121 SQAD01122 SQAD01123 SQAD01124 SQAD01125 SQAD01127 SQAD01130 SQAD01132 SQAD01134 SQAD01135 SQAD01136 SQAD01137 SQAD01138 SQAD01139 SQAD01141 SQAD01193 SQAD01197 SQAD01198 SQAD01199 SQAD01200 SQAD01203 SQAD01076 SQAD01080 SQAD01081 SQAD01082 SQAD01083 SQAD01089 SQAD01090 SQAD01091 SQAD01092 SQAD01093 SQAD01094 SQAD01095 SQAD01096 SQAD01097 SQAD01098 SQAD01099 SQAD01104 SQAD01106 SQAC01283 SQAC01049 SQAC01062 SQAC01073 SQAC01274 SQAC01234 SQAC01509 SQAD00002 SQAC00937 SQAC00940 SQAD00009 SQAC00939 SQAC01144 SQAD00376 SQAC00932 SQAD00010 SQAC00821 SQAC00822 SQAC00879 SQAC01497 SQAD00014 SQAD00021 SQAD00209 SQAD00210 SQAD00212 SQAD00207 SQAD00211 SQAC00929 SQAD00841 SQAD00018 SQAD00359 SQAC01504 SQAC00928 SQAD00374 SQAD00381 SQAD00384 SQAD00388 SQAD00390 SQAD00391 SQAD00405 SQAD00407 SQAD00408 SQAD00410 SQAD00411 SQAD00023 SQAC00758 SQAC00764 SQAD00011 SQAC01284 SQAD00443 SQAC01138 SQAC01278 SQAC00926 SQAD00197 SQAD00217 SQAC00933 SQAC00935 SQAC00946 SQAC00959 SQAC00960 SQAC01133 SQAD00445 SQAD00448 SQAD00465 SQAC01247 SQAC01246 SQAD00191 SQAD00446 SQAC01134 SQAC01449 SQAC01450 SQAD00208 SQAD00013 SQAD00845 SQAD01079 SQAD01102 SQAC01455 SQAC01456 SQAD00444 SQAD00449 SQAD00453 SQAD00454 SQAD00215 SQAC01140 SQAC01141 SQAC01341 SQAC01358 SQAC01359 SQAC01360 SQAD00204 SQAC01338 SQAD00205 SQAC01505 SQAC01506 SQAC01459 SQAC01501 SQAC00931 SQAD00218 SQAD00219 SQAD00226 SQAD00015 SQAC00936 SQAC00942 SQAC00945 SQAC00954 SQAC00962 SQAC00934 SQAD00440 SQAC00943 SQAC01448 SQAD00213 SQAD00216 SQAC00951 SQAC00819 SQAC01502 SQAD00221 SQAC01446 SQAC01490 SQAD00223 SQAC00947 SQAC00961 SQAD00442 SQAD00206 SQAC01469 SQAC00513 SQAC00641 SQAC00769 SQAC00859 SQAC00862 SQAC00884 SQAC00888 SQAC00889 SQAD00263 SQAD00001 SQAD00003 SQAD00022 SQAC00509 SQAC00511 SQAC00529 SQAC00530 SQAC00644 SQAC00770 SQAC00771 SQAC00778 SQAC01015 SQAC01043 SQAC01112 SQAC01115 SQAC01148 SQAC01178 SQAC01188 SQAC01191 SQAC01210 SQAC01288 SQAC01334 SQAC01356 SQAC01377 SQAC01499 SQAD00237 SQAD00240 SQAD00246 SQAD00247 SQAD00478 SQAD00479 SQAD00485 SQAD00706 SQAD00713 SQAD01078 SQAD01084 SQAD00481 SQAD00558 SQAD00582 SQAD00592 SQAD00594 SQAD00597 SQAD00932 SQAD01023 SQAD01058 SQAD01066 SQAD01142 SQAD01175 SQAD01223 SQAC00672 SQAC00674 SQAC00675 SQAC00676 SQAC00678 SQAC00684 SQAC00691 SQAC00696 SQAC00741 SQAC00765 SQAC00843 SQAC00847 SQAC00848 SQAC00849 SQAC00850 SQAC00993 SQAC00994 SQAC00995 SQAC00997 SQAC00998 SQAC01075 SQAC01076 SQAC01078 SQAC01079 SQAC01080 SQAC01089 SQAC01102 SQAC01103 SQAC01104 SQAC01105 SQAC01107 SQAC01108 SQAC01110 SQAC01117 SQAC01118 SQAC01119 SQAC01290 SQAC01291 SQAC01292 SQAC01293 SQAC01295 SQAC01300 SQAC01301 SQAC01302 SQAC01303 SQAC01304 SQAC01306 SQAC01307 SQAC01308 SQAC01309 SQAC01342 SQAC01345 SQAC01352 SQAC01362 SQAC01368 SQAC01369 SQAD00406 SQAD00569 SQAD00573 SQAD00575 SQAD00579 SQAD00925 SQAD00945 SQAD00950 SQAD00958 SQAD00966 SQAD01014 SQAD01015 SQAD01028 SQAD01029 SQAD01034 SQAD01056 SQAD01057 SQAD01059 SQAD01071 SQAD01074 SQAC00603 SQAC00642 SQAC00654 SQAC00655 SQAC00726 SQAC00739 SQAC00820 SQAC01165 SQAC01253 SQAD00762 SQAD01052 SQAD00475 SQAD00476 SQAD00477 SQAD00474 SQAD00487 SQAD00488 SQAD00492 SQAD00493 SQAD00742 SQAC01157 SQAC01158 SQAC01161 SQAC01173 SQAD00886 SQAC01318 SQAC01320 SQAC01346 SQAC01349 SQAC01404 SQAC01422 SQAC00812 SQAC00984 SQAC00985 SQAC00991 SQAC00992 SQAC00996 SQAC01395 SQAC01400 SQAC01406 SQAC01412 SQAC00633 SQAC00768 SQAC00774 SQAC00780 SQAD01183 SQAC00880 SQAC00882 SQAD00358 SQAD00852 SQAD00854 SQAD00858 SQAD00884 SQAD01213 SQAD00885 SQAD00607 SQAD00608 SQAD00609 SQAD00615 SQAD00682 SQAC00979 SQAD00331 SQAD00334 SQAD00565 SQAD00996 SQAD00999 SQAD01036 SQAD01040 SQAD01042
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 2		Process control
ActionAn 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 Commerce644 units
DistributionUS Nationwide. Global Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAD
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