Reported Apr 19, 2017 · Terminated
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
Vivid S60/S70/S60N/S70NH45041SUH45041SWH45581MSH45581PD
- Lot codes and dates
- Mfg. Lot or Serial # System IDNot Available
121 of 121 codes
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
Not Available 001250S70 Not Available001256S60VS60001256001003S70VS70001003001332S60VS60001332001347S60VS60001347001329S60VS60001329001310S60
Not Available000969S70VS70969S70000971S7000123ULT34000966S7000111ULT15001023S7000111ULT14001046S7000982ULT02001036S7000506ULT19001072S7020347ULT03001117S6000058ULT15001175S7000115ULT16001298S7000149ULT44001340S7000004ULT17001150S7000199ULT36001264S7000199ULT39001260S7000199ULT37001254S7000199ULT36000978S7000459ULT17001322S7000624ULT30001307S7000136ULT11001309S7021367ULT01001354S6000195ULT26001337S7000296ULT13001002S700853380377001182S70529040US21001325S70
Not Available001114S70A004US71000960S70O009US94001113S70A042US13001140S70BD003US38001171S70A042US14001190S70MPX43159001174S60
Not Available001146S60GON4457540001172S60GON4422820001143S70C999992841104S70NZA2785US011106S70NZA2790US011103S70NZA2820US011198S60NZA2945US01592S70NZA2820US021107S70N
Not Available001417S60GON4445496001400S706073UL03191366S60NSA2517US011194S60NSA2511US01001242S70RU7950US05001231S70RU1173US06001257S70RU6396US07001393S70600152US07001042S60
Not Available 001279S70 Not Available 001099S70 Not Available 001179S60 Not Available 001234S60 Not Available 001224S60 Not Available 001324S60 Not Available 1200S70N Not Available001034S60RO4186US12001151S60RE1110US011105S60NQA1046US02001115S60PER46108001167S70PL1698US08001080S70PL7475US03001215S70PL1334US09001192S601557UL0338000977S70VS70977S701368S60NGON4436983001173S70
Not Available89 of 89 codes
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
Not Applicable001177S70A470456401001369S70A5935902001394S70A5289906000029S70A5113139001033S70
Not Available 001331S70 Not Available907S60NIR2197US011367S60N5512UL0905001152S70083038820115216001152S70083038820115216001281S70083038800060616001213S70083038800148317/083038801699017001327S70083038804905016986S70N083038604420116001083S70HUDUS0525001084S70HUDUS0527001095S70HUDUS0526001094S60HUDUS0123001243S70HUDUS0420001241S70HUDUS0421001396S70HUDUS0489001387S60HUDUS0183001412S60HUDUS0184001407S70HUDUS0182001131S70HUDUS0354001330S700828380483001097S60GP1112US01001216S60H2105US04001216S60H2105US04001305S70H22421US02001270S70
Not Available 000946S60 Not Available 000956S60 Not Available 000958S60 Not Available171 of 171 codes
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
Not Applicable001148S60GON4423471001183S60U437830301001185S60U437830302001220S60US30003301001222S70U464557301001315S60US31001301001314S60U470803601000937S60US78044607001038S70
Not Available87 of 87 codes
000957S60U287989802000961S60USM4198037000959S60USM4198036000967S60US29066206000968S60US88657318001031S70US26187813001035S70USM2505607001109S60US50272418001127S70US88657317001126S70USM4177308001111S60US50272417001144S70USN4165408001147S70U151064604001153S70U151064605001189S60USM2505317001186S70U276410807001178S70USN4165409001204S70USM4166011001168S60001168S60001219S70USM3183518001228S70USM4329426001232S60USM4477110001240S60USN4213405001225S70U243851504001271S60USM4497217001267S70USM2607019001278S70USM2607020001280S70USM4482808001283S70US67382203001287S60US41892022
Not Available001217S70FI1063US29001223S70FI1032US07001229S70FI1063US28000979S70DK1022US54000954S70
Not Available001255S70DK1090US21001320S70DK1058US42001262S70DK1022US58001027S60CZ6403US02001317S70CZ6001US09000999S70416778VS70001037S70416494VS70001335S70416446VS70001370S70
Not Available 001385S70 Not Available 001410S70 Not Available001202S60VS601202S60000972S70030042US13001102S70030392US15001235S60030419US12001237S60030419US13001386S70030392US17001030S70947667US02001032S60568080US02000753S70100029US11001205S70220166US25001208S70190105US28001416S70701697US01001207S60190171US13001170S70701708US01001388S60
Not Available 001193S60 Not Available001226S70AH1912US32001273S70AH5045US11000952S7083150625712001017S7083151375114001123S7083152818712001180S7083152648280001277S7083154415380001269S7083153232163001276S7083154414988001285S7083154415943001101S70
- Mfg. Lot or Serial # System ID
- Amount recalled
- 396 (67 US; 329 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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