GE Medical Systems, LLC recalls Tec 6 Plus 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 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
Lot / 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 #
AESC31001 AESC31009 AESC32001 AESC32004 AESC32007 AESC29004 AESD02013 AESC11019 AESC11022 AESC13002 AESC13024 AESC24015 AESC25017 AESC28017 AESC22013 AESD15005 AESD15011 AESC13011 AESC23007 AESC25004…Show all
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 AESD12023 AESD12024 AESD12025 AESD12026 AESD12027 AESD12028 AESD13001 AESD13002 AESD13004 AESD13006 AESD13007 AESD13008 AESD13009 AESD13010 AESD13012 AESD13014 AESD13016 AESD13017 AESD13018 AESD13019 AESD13021 AESD13022 AESD13023 AESD13024 AESD13025 AESD13026 AESD13027 AESD13028 AESD13029 AESD13031 AESC21017 AESC29001 AESC31008 AESC34010 AESC43014 AESD10008 AESD11003 AESD11004 AESD14004 AESD14008 AESD14011 AESD14013 AESD14016 AESC23025 AESC24016 AESC24021 AESC25007 AESC25010 AESC25013 AESC25015 AESC25019 AESC25021 AESC25026 AESC27010 AESC27013 AESC30020 AESC34002 AESD19002 AESC44007 AESC49003 AESC49024 AESC50017 AESD01009 AESD12020 AESD14009 AESD14017 AESD15006 AESD15012 AESD15013 AESD16002 AESD16003 AESD16006 AESD16008 AESD16018 AESD16019 AESD17005 AESD17008 AESD18009 AESD20007 AESD20013 AESD20015 AESD20025 AESD21008 AESD21013 AESD21015 AESD21019 AESD21030 AESD25013 AESD26014 AESD30037 AESD31024 AESD31034 AESC20004 AESC23022 AESC23024 AESC16003 AESC21010 AESC43021 AESC48007 AESC48015 AESC48019 AESC48021 AESC38007 AESC44002 AESC44020 AESC46005 AESC50019 AESD02008 AESD03008 AESD03009 AESD03010 AESD03012 AESD03014 AESD04003 AESD04005 AESD04010 AESD04012 AESD04014 AESD04015 AESD04016 AESD05001 AESD05002 AESD05004 AESD05006 AESD05007 AESD05008 AESD05009 AESD06008 AESD06012 AESD06013 AESD06014 AESD07001 AESC37013 AESC23045 AESC26003 AESC44014 AESC48014 AESC48023 AESC48025 AESC48027 AESC48029 AESC49023 AESC48020 AESC51010 AESD33022 AESC06026 AESC21021 AESC23020 AESC30014 AESC47009 AESC48026 AESC49025 AESD31026 AESC14019 AESC36007 AESD11014 AESD22018 AESD23006 AESD11015 AESC11017 AESD07007 AESD03017 AESD03019 AESC20001 AESC13015 AESC13016 AESC13018 AESC13019 AESC14011 AESC14015 AESC23047 AESC35007 AESD20008 AESC50012 AESD20009 AESC16004 AESC21005 AESC23046 AESC24007 AESC25011 AESD16004 AESD19004 AESC23044 AESC24001 AESC48013 AESC33004 AESD20031 AESD20003 AESC19013 AESC21004 AESC22004 AESC22005 AESC22006 AESC23011 AESC23013 AESC23036 AESC24011 AESD16009 AESD16011 AESC24008 AESC38003 AESC43004 AESC43007 AESC43015 AESC43020 AESC46006 AESC35002 AESC13025 AESC49021 AESD31049 AESC42009 AESC42012 AESC33006 AESC43003 AESD31038 AESC51009 AESC24023 AESC25005 AESC21024 AESC22003 AESD07003 AESC44013 AESC49005 AESD20030 AESD04001 AESC32002 AESD06003 AESD21020 AESD23011 AESC23003 AESC23008 AESC23023 AESC23026 AESC23030 AESC27009 AESD04002 AESD04004 AESD04007 AESC16014 AESC37017 AESD02005 AESD02012 AESD21003 AESD21011 AESD21018 AESD22031 AESC34006 AESD13034 AESD21023 AESC11012 AESD16007 AESC42024 AESB23021 AESB24010 AESC16009 AESB40023 AESC11016 AESC13009 AESC13014 AESC13026 AESC14018 AESC14020 AESC15007 AESC15011 AESC15012 AESC15014 AESC15016 AESC15017 AESC15020 AESC16002 AESC16007 AESC18008 AESC19008 AESC19011 AESC20002 AESC21001 …
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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-0814-2025
- FDA 510(k) clearance · K000275The 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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