Class 2 Device Recall Tec 6 Plus

• Date Initiated by Firm: November 18, 2024
• Date Posted: January 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0814-2025
• Recall Event ID: 95855
• 510(K)Number: K000275
• Product Classification: Vaporizer, anesthesia, non-heated - Product Code CAD
• Product: Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992
• Code Information: REF 1107-9601-000, GTIN 0084068211253; REF 1107-9602-000, GTIN 00840682112659; REF 1107-9603-000, GTIN 00840682112574; REF 1107-9604-000, GTIN 00840682112925; REF 1107-9610-000, GTIN 00840682112864; REF 1107-9612-000, GTIN 00840682113236; REF 1107-9616-000, GTIN 00840682113069; REF 1107-9617-000, GTIN 00840682112666; REF 2066835-001, GTIN 00840682112857; REF 2069767-001, GTIN 00840682112505; REF 2078800-001, GTIN 00840682112512; REF 2091008-001, GTIN 00840682112437; REF 2091009-001, GTIN 00840682112802; REF M1098876, GTIN 00840682112710; REF M1145610, GTIN 00840682112765; REF M1220023, GTIN 00840682112789; REF M1220854, GTIN 00840682112826; REF M1221495, GTIN 00840682115902; REF M1233992, GTIN 00840682112451; Serial Numbers: AESC31001 AESC31009 AESC32001 AESC32004 AESC32007 AESC29004 AESD02013 AESC11019 AESC11022 AESC13002 AESC13024 AESC24015 AESC25017 AESC28017 AESC22013 AESD15005 AESD15011 AESC13011 AESC23007 AESC25004 AESD31023 AESC13020 AESC16013 AESC17013 AESC20007 AESC22007 AESC22020 AESC23005 AESC23009 AESC23012 AESC29031 AESC11018 AESD15009 AESD15017 AESD16001 AESC50022 AESD08005 AESD10013 AESD10016 AESD11012 AESD11013 AESD12001 AESD12002 AESD12011 AESD20017 AESD22023 AESC30010 AESC42010 AESC42018 AESC43024 AESC43028 AESC44003 AESC44004 AESC44006 AESC44019 AESD31013 AESD31028 AESD01017 AESC46003 AESC47012 AESC48003 AESC48011 AESC11020 AESC23051 AESC13017 AESC30015 AESD15001 AESC24024 AESC10013 AESC21027 AESC45012 AESC48004 AESC50006 AESC50010 AESD07008 AESC30019 AESC32006 AESC43027 AESD13015 AESC45010 AESC43025 AESC50004 AESC50003 AESC50018 AESC50023 AESC50026 AESC51011 AESC50009 AESD07011 AESD08002 AESD08003 AESD08004 AESD08007 AESD08010 AESD08011 AESD08017 AESD09006 AESD11001 AESC29020 AESC24004 AESC29025 AESD31001 AESD31025 AESC44016 AESC11021 AESC03005 AESC08007 AESD12007 AESD12012 AESD12013 AESD12014 AESD14007 AESB49025 AESC13013 AESC21029 AESC21033 AESD15014 AESC21002 AESC32003 AESC45001 AESC45009 AESC45014 AESC49004 AESC09010 AESC10009 AESC11013 AESC11014 AESC39016 AESD14015 AESC29018 AESC25002 AESC50024 AESC25003 AESC08003 AESD12005 AESD12006 AESD12008 AESD12015 AESB11014 AESC16010 AESC17001 AESC22009 AESC16008 AESD21002 AESC23031 AESC25001 AESC25018 AESC25020 AESC26004 AESC27012 AESC47007 AESC48009 AESC48016 AESD23003 AESC31016 AESC39018 AESC49019 AESD02011 AESD05012 AESD07002 AESD07006 AESD31014 AESC17009 AESC23018 AESC44009 AESD15007 AESD19007 AESC29032 AESC43002 AESC44005 AESC44018 AESD21028 AESD22025 AESD23010 AESC10003 AESC10011 AESB10008 AESC08022 AESD22016 AESD07004 AESD07005 AESC47008 AESD08008 AESC44012 AESC11024 AESC39014 AESD32010 AESD37010 AESD37036 AESD38006 AESD38017 AESD39014 AESD39017 AESD39021 AESD39022 AESC13006 AESC20008 AESC21007 AESC21034 AESC22016 AESC23002 AESC23004 AESC23010 AESC23016 AESC23019 AESD07012 AESC29024 AESC30008 AESD22030 AESD24008 AESD25008 AESY40038 AESB10007 AESB33013 AESC09024 AESC10017 AESC10020 AESC10022 AESC10025 AESC10026 AESC10032 AESC10033 AESC11004 AESC11005 AESC11007 AESC11008 AESC11009 AESC25024 AESC25027 AESD12017 AESC28001 AESC23021 AESC24012 AESC30009 AESC30012 AESC31005 AESD31002 AESD31017 AESD31021 AESD31022 AESC24005 AESC25008 AESC32010 AESC32013 AESC32015 AESC32008 AESC32012 AESC32014 AESC29019 AESC30001 AESC27007 AESC28024 AESC29012 AESC29013 AESC29014 AESC29021 AESC29023 AESC29027 AESC30007 AESC11003 AESC24030 AESC29017 AESC29022 AESD21026 AESD22017 AESD22021 AESD22024 AESD22028 AESD13011 AESD19005 AESD20002 AESD20005 AESD20026 AESD20027 AESD20028 AESD21012 AESD21017 AESD21021 AESD21024 AESD21027 AESD21031 AESC13023 AESC14001 AESC14009 AESC15004 AESC15019 AESC17003 AESC18003 AESC18004 AESC18005 AESC18009 AESC18010 AESC18011 AESC18012 AESC18013 AESC19001 AESC19002 AESC19003 AESC19005 AESC19007 AESC19009 AESC19010 AESC19014 AESC20003 AESC50011 AESC50013 AESC39010 AESC45008 AESD06010 AESD07010 AESD08014 AESD09012 AESD09016 AESD10021 AESD11006 AESD11011 AESD12004 AESD12009 AESD12010 AESD12016 AESD12018 AESD12019 AESD12021 AESD12022 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AESC46009 AESC47016 AESC39017 AESC42002 AESC11011 AESD10017 AESD10020 AESC37010 AESC32009 AESD31036 AESC36006 AESC37005 AESC37015 AESC11023 AESC13007 AESC13008 AESC45015 AESC50025 AESC13001 AESD22010 AESC13012 AESC17010 AESC37024 AESC36003 AESC21025 AESC29015 AESC30024 AESD20011 AESD21016 AESC32018 AESC14003 AESC29005 AESC37008 AESD15016 AESC25023 AESC26001 AESD01003 AESD01008 AESD03001 AESD03002 AESD03005 AESC15001 AESD01005 AESC47004 AESC11015 AESD02003 AESD33002 AESC15002 AESD22014 AESC09018 AESC42007 AESC51006 AESC51007 AESC23048 AESC24027 AESC49028 AESC28007 AESC29011 AESC35012 AESC29008 AESC42005 AESD01014 AESC19004 AESC42014 AESC50002 AESD06001 AESC21030 AESD20012 AESD25006 AESD25009 AESD25010 AESC28015 AESC48001 AESC35011 AESC35005 AESC14008 AESC09033 AESC48030 AESC27014 AESC16001 AESC50015 AESD23012 AESC14006 AESC29010 AESD23008 AESD01007 AESD10006 AESC50016 AESD24003 AESD24006 AESD09004 AESD31040 AESD31041 AESC43019 AESD09017 AESC17008 AESD20006 AESD21010 AESD24022 AESD17006 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AESC46015 AESC46018 AESC46019 AESC47005 AESC49011 AESC51001 AESD06004 AESD13013 AESD13020 AESD14002 AESD14014 AESD14019 AESD15002 AESD15008 AESD15010 AESD15015 AESD17001 AESD30023 AESD30035 AESD32001 AESC47010 AESC47011 AESC47013 AESD09018 AESD19008 AESD31035 AESC24017 AESC43001 AESC50001 AESC37011 AESC38004 AESD22029 AESD32002 AESD31007 AESC14016 AESC28012 AESD31033 AESC30004 AESD23013 AESC46011 AESC15008 AESD17003 AESB40017 AESC20006 AESC22012 AESD05003 AESC25031 AESC37016 AESC38005 AESC38009 AESC48012 AESC22001 AESD13033 AESB33026 AESD10015 AESD11005 AESD03007 AESD10009 AESD19012 AESD21004 AESC32016 AESC23006 AESC30003 AESC30006 AESD31050 AESD31051 AESC28023 AESD02002 AESC15015 AESD06006 AESC28013 AESD19006 AESC17002 AESC21012 AESD23017 AESD23026 AESD24007 AESD24011 AESD24014 AESD24020 AESD24021 AESD20024 AESC46007 AESC45007 AESC17004 AESC17006 AESC17012 AESD16013 AESC13021 AESC23035 AESC43013 AESC51008 AESC51004 AESC42021 AESD10010 AESC26002 AESC29003 AESC49014 AESC49013 AESC46002 AESD10012 AESC14002 AESC33008 AESC48028 AESC49010 AESC49018 AESC09037 AESD22032 AESD06002 AESC29016 AESC35008 AESC43009 AESD01001 AESD01002 AESC21015 AESC24029 AESC25022 AESC27016 AESD04011 AESD23002 AESC16011 AESD05011 AESC23041 AESC47014 AESC32019 AESC14012 AESC21035 AESC42025 AESC35014 AESD22004 AESC17014 AESD01016 AESC48022 AESD23007 AESD20001 AESD20014 AESC48017 AESC28006 AESC28008 AESD31042 AESD31043 AESC46010 AESC51003 AESD02001 AESD23020 AESC15009 AESD03018 AESC28021 AESC23032 AESC33001 AESC42013 AESC42015 AESC28014 AESC23050 AESD23009 AESC28003 AESD23021 AESC42023 AESC51005 AESD23004 AESC40003 AESC38010 AESC38018 AESB07001 AESC13010 AESD20016 AESD18001 AESC43022 AESC49001 AESC22014 AESC40002 AESC42011 AESC42017 AESD09013 AESC29006 AESD03006 AESD23001 AESD08009 AESC37009 AESD18005 AESC43026 AESC44011 AESC44017 AESC45002 AESC45004 AESC45005 AESD09011 AESD09015 AESD11010 AESD11016 AESD12003 AESD31027 AESC17007 AESD03004 AESC22018 AESC26005 AESC28002 AESC38020 AESC38021 AESC49026 AESB40007 AESC10018 AESC11006 AESC11010 AESD09009 AESD10002 AESD13005 AESC11025 AESC14004 AESC15006 AESC18007 AESC19006 AESC20005 AESC20009 AESC20010 AESC21008 AESC21031 AESD30024 AESD30031 AESC36001 AESC43006 AESC43008 AESC43016 AESD30032 AESD31010 AESC38019 AESD30025 AESD30028 AESC37014 AESD25001 AESC38011 AESD18010 AESD31016 AESD25018 AESD28004 AESD29013 AESD29024 AESD30001 AESD21022 AESD25019 AESD26005 AESD26009 AESD26010 AESD26011 AESD26015 AESD26016 AESD16015 AESD17004 AESD22011 AESD25017 AESD25020 AESD25021 AESD25022 AESD26001 AESD26002 AESD26003 AESD26020 AESD26021 AESD28001 AESD19016 AESD21029 AESD30004 AESD30015 AESD30016 AESC14010 AESD29001 AESD29002 AESD29011 AESD29014 AESD26004 AESD29025 AESD30003 AESD30012 AESD18011 AESD25014 AESD25016 AESD31006 AESD31012 AESD30021 AESD30026 AESD31004 AESD31005 AESD24010 AESD25007 AESC33011 AESC37023 AESC38016 AESC38022 AESC39004 AESC39009 AESC39015 AESC37004 AESC39002 AESC37026 AESC39003 AESC43012 AESC38002 AESC38006 AESD26013 AESD29020 AESD30010 AESD30009 AESD30033 AESD25011 AESC13004 AESD22019 AESD23022 AESD26012 AESD26017 AESD28003 AESC38008 AESC39008 AESD29007 AESD29026 AESD29027 AESD30006 AESD30014 AESD29010 AESD29012 AESD29015 AESD29018 AESD29021 AESD26008 AESD26018 AESD29005 AESD29006 AESD29008 AESD29009 AESD10019 AESD30018 AESD31009 AESD29016 AESD29017 AESD29019 AESD29022 AESD29023 AESC39019 AESC40004 AESC42001 AESC42004 AESD30017 AESD30022 AESD30029 AESC39020 AESD30007 AESD30020 AESD30027 AESD10014 AESD20004 AESD26019 AESD25015 AESC25006 AESC38017 AESC39013 AESD26006 AESD28002 AESD29003 AESD29004 AESC35016 AESC38012 AESD30005 AESD30011 AESD30013 AESD30030 AESC37019 AESC39001 AESC39012 AESC40001 AESD30002 AESD30008 AESD30019 AESC36009 AESC39006 AESC39011 AESD04017 AESC18002 AESC21009 AESC37020 AESC48018 AESC49017 AESC50007 AESC50020 AESC50021 AESD01004 AESD01010 AESD31019 AESC15005 AESC15013 AESC18006 AESC21006 AESC21016 AESD13003 AESC24026 AESD07013 AESC19016 AESC23015 AESC24013 AESC28026 AESC25030 AESC29030 AESC39005 AESC44015 AESC48024 AESD02007 AESD02015 AESC45011 AESC46001 AESC30017 AESC31014 AESC02001 AESC22011 AESC23043 AESC24010 AESC24020 AESC24022 AESC25012 AESC27018 AESC29026 AESC30016 AESC30022 AESC31003 AESC31004 AESC31011 AESC31013 AESC32017 AESC38001 AESC39007 AESC45003 AESC45013 AESC46004 AESC47015 AESD06007 AESD11008 AESD22005 AESC48010 AESC24028 AESC33003 AESB33008 AESC30011 AESC30023 AESC23039 AESC23029 AESC25014 AESC23034 AESC30021 AESC25032 AESC27008 AESC29029 AESC30013
• 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: 1573 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