FDAFDA · Alimentos y medicamentos·N.º oficial Z-1780-2017
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Publicado el 19 de abril de 2017 · Inicio del retiro: 10 de marzo de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India, Hungary, Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic, Croatia, Colombia, Chile, Canada, Bulgaria, Brunei Darussalam, Brazil, Belgium, Austria, Australia, Argentina, Vietnam. Uruguay, Taiwan, Slovakia, Singapore, Reunion, Qatar, Panama, Pakistan, Jordan, Indonesia, Guadeloupe, Czech Republic
- Lote
- Mfg. Lot or Serial # System ID 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997 001022S70 VS70001022 001020S70 VS70001020 000941S70 VS70000941 000951S70 VS70000951 000982S70 VS70000982 000981S70 VS70000981 000994S70 VS70000994 000976S70 VS70R000976 000993S70 VS70000993 000980S70 VS70000980 000998S70 VS70R000998 000996S70 VS70000996 001005S70 VS70001005 001010S70 VS70001010 001007S70 VS70001007 001008S70 VS70001008 001021S70 VS70001021 001029S70 VS70001029 001040S60 VS60001040 001052S70 VS70001052 001048S70 VS70001048 001051S70 VS70001051 001066S60 VS60001066 001054S60 VS60001054 001059S70 VS70001059 001064S70 VS70001064 001067S70 VS70001067 001062S70 VS70001062 001047S70 VS70001047 001050S70 VS70001050 001073S70 VS70001073 001076S70 VS70001076 001078S70 VS70001078 001074S70 VS70001074 001129S70 VS70001129 001120S60 VS6001120 001137S70 VS70001137 001157S70 VS70001157 001230S60 VS60001230 001246S60 VS60001246 001253S60 VS6001253 001336S60 VS6001336 001345S60 VS60001345 000948S70 VS70000948 000995S70 VS70000995 001053S70 VS70001053 001055S60 VS60001055 001056S70 VS70001056 001039S70 VS70001039 001060S70 VS70001060 001069S70 VS70001069 001112S60 VS60001112 001128S70 VS70001128 001138S70 VS70001138 001163S70 VS70001163 001165S70 VS70001165 001238S60 Not Available 001256S60 VS60001256 001003S70 VS70001003 001332S60 VS60001332 001347S60 VS60001347 001329S60 VS60001329 001310S60 Not Available 001250S70 Not Available 000969S70 VS70969S70 000971S70 00123ULT34 000966S70 00111ULT15 001023S70 00111ULT14 001046S70 00982ULT02 001036S70 00506ULT19 001072S70 20347ULT03 001117S60 00058ULT15 001175S70 00115ULT16 001298S70 00149ULT44 001340S70 00004ULT17 001150S70 00199ULT36 001264S70 00199ULT39 001260S70 00199ULT37 001254S70 00199ULT36 000978S70 00459ULT17 001322S70 00624ULT30 001307S70 00136ULT11 001309S70 21367ULT01 001354S60 00195ULT26 001337S70 00296ULT13 001002S70 0853380377 001182S70 529040US21 001325S70 Not Available 001114S70 A004US71 000960S70 O009US94 001113S70 A042US13 001140S70 BD003US38 001171S70 A042US14 001190S70 MPX43159 001174S60 Not Available 001146S60 GON4457540 001172S60 GON4422820 001143S70 C99999284 1104S70N ZA2785US01 1106S70N ZA2790US01 1103S70N ZA2820US01 1198S60N ZA2945US01 592S70N ZA2820US02 1107S70N Not Available 001417S60 GON4445496 001400S70 6073UL0319 1366S60N SA2517US01 1194S60N SA2511US01 001242S70 RU7950US05 001231S70 RU1173US06 001257S70 RU6396US07 001393S70 600152US07 001042S60 Not Available 001034S60 RO4186US12 001151S60 RE1110US01 1105S60N QA1046US02 001115S60 PER46108 001167S70 PL1698US08 001080S70 PL7475US03 001215S70 PL1334US09 001192S60 1557UL0338 000977S70 VS70977S70 1368S60N GON4436983 001173S70 Not Available 001279S70 Not Available 001099S70 Not Available 001179S60 Not Available 001234S60 Not Available 001224S60 Not Available 001324S60 Not Available 1200S70N Not Available 000953S60 NO4005U120 000970S70 NO4031US24 001000S70 NO4068US85 001169S70 NO4088US60 001218S60 NO4202US03 001316S60 NO4442US01 001221S60 8315344197 001012S60 0850372938 001093S70 0850372991 001108S70 0850372993 001098S70 0850372992 001265S70 0850373034 001284S60 0850373074 001311S60 0850373460 001312S70 0850373120 001313S70 0850373117 001326S70 0850373109 1195S60N JO4041US03 1196S70N JO4041US04 000944S60 QEA060 001011S60 QEA061 001014S60 QEA062 001016S60 QEA064 001015S60 QE0063 001085S60 QE0065 001092S60 QE0066 001203S70 QE0067 001239S60 UX9652 001247S60 QE0069 001233S60 QE0073 001248S60 QE0075 001245S60 QE0074 001244S70 QE0071 001249S70 QE0072 001227S70 QE0070 001261S60 QE0076 001286S70 QE0078 001275S70 QE0077 001282S60 QE0080 001258S70 QE0079 001304S70 QE0084 001341S60 QE0083 001328S60 QE0082 001299S60 QE0081 001292S70 Not Available 001177S70 A470456401 001369S70 A5935902 001394S70 A5289906 000029S70 A5113139 001033
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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