FDAFDA · Alimentos y medicamentos·N.º oficial Z-2733-2024
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
Publicado el 4 de septiembre de 2024 · Inicio del retiro: 12 de julio de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare (China) Co., Ltd.
- Distribuidor
- Worldwide distribution.
- Lote
- 1) 2259973: UDI/DI none: System ID Numbers: 918485PROT1, 281410PRO; UDI/DI 00840682120777: System ID Number 503315PRO; 2) 2259988: UDI/DI 00840682106139: System ID Numbers: 305682PROTEUS, 305MCPCPRO, 828262PROT, 631376ER2, 716675DPRO1, 206965XR; UDI/DI 00840682120777: System ID Numbers: 251435PROT, 334418PRO, 334418XRA, 520MERPRO, 805652DR2, 303320TPXR, 970248PROT, 203732PROT, 203876XRA564, 941792PROTEUS, 305CGHPROTEUS, 561495RAD1, 850837PROTEUS, 352FRIPRO, 386LCMCER1, 813344PROTXR, 561881ICRAD, 850469PROT, 561655XRA, FWR1453, 478289PRO, 847298AMGPROT, 630225NWMGE02PXRA, 630225NWMGEO1D, 630241PROT, 317439PROT, 317338SPORTS, 317773PROT, 317204PROT, 913491PROXR1, 620421PRO1, 785543PRO, 785743PRO, 598761NVP, 906483XRA564, 313745RERPROT, 1000001522, 601855PROTEUS, 662773RAD1, 662756PRO, 704323FA, 704323PROS, 908237RAD, 201656PROT, 575439PROT, 585227PRO1, 914964PROT, 740HVCHPRO, 740333PROT1, 740FAYPRO, 724547XR1, 864512KCPROT, 843681PROTEUS, 843839XR, 901767PROTXR, 737202PROT, SDNAMCTRAUMA, 281897XRPRO, 254751PROLL, 512SDMCLER, 254751XRA, 804TRIPRO, 804285PRO1, 804285PRO2, 540970ER, 360475PSNSPROT, 509674CEX1, 920907PROT1, 414529PRO1, 608785PROTBEL, 414385PRO1, 414978PRO, 414570PRO1, 920303PROT1, 262542PROXRA, 414479PRO4, 414607PROXR1, 905732RAD2, RU8366RX01, ZA2985RX01, 34442RAD01, XR1383UY; UDI/DI none: System ID Numers: 907842PROTX, 907796ORTHO, 907796PROT, 907443PROTEUS, 907861VER, 256235ORT1, 251368ARAD, 205481PRO, 205592DCPRO, 251847RAD, 205280PRO, 256737PRO, 251435R1, 251275RAD, 256486XR1, 256429CR2, 256782PRO1, 205387PRO, 256CCP1, 256974PR1, 334732PXRA, 256332RRM1, 256356RAD1, 256386RM4, 334670RAD, 205750RAD, 256487RAD, 870898PROT, 479BVXR, 479709PROT, 870816PROT, 501622PROT, 870972PRO1, 870972PRO2, 870245PROT, GON4605254, 870508BJC1, 870845PROT2, 501202BNLER, 870541PROT6, 479338PROT1, 501268PROT2, 870673PROT, 870226PROT, 870208RF, 870208XR1, 623925XR1, 480FCCHDXR, 480MAYOXR, DAZGHCHD2XR, 480603XR1, 520228PRO, 520533PRO1, 928758RAD, 480984XR1, 623433XR1, 623FCGLEXR, PHXCAM1XR1, RADNETRAD400, 623322XR, 928453DR2, 928453UCXR1, DAZMESAXR, PHXGIL1XR1, 520498PR1, 520498PR2, 602ARROWPROT, 623SPPLZPRO, RADNETRAD401, 602251XR1, 602867RM3, 602923PRO1, 623327XR3, DAZPHX44XR, RADNETRAD398, 602285PROT2, 602285PROT1, 623445PROT, 602239ER1, 602246RM4, 602562PROT, 928348PRO, 928348PRO2, 480DSANXR, 520SVPRO, 623876PROT, PHXBEL1XR1, 480DTEMXR, 520STJOPRO, 520VNWPRO, 702383XR4, 949517RM4, 671AAFBPRXRA, 808KWAJPROT, RADNETRAD352, 661395BC1, RADNETRAD371, 661327RAD1, 530BAFPRO, CVSPRAD1, 818563DR, 925674RAD6, 707464RAD1, 650DCSETON, 916351PRO1, 510797RM1, 510797W5, 559459XR1, 559459XR2, 559459XR3, 714537RM3, 408885GIL, 818952DRER, 626914RAD, 530BGPRO, 408636PROTEUS, 801774ER, 949764RM1, 209223PROTAM1, 760366ER, 619644PRO2, 619644PRO3, 909336RAD2, 760379RAD, 925734RAD1, 262951PRO, 805737RAD1, 760876RAD, 213744PROTXR1, 213744PROTXR2, 760934OP1, 925370ORTHO2, 925370ORTHO1, 408885MIL, 408957ECF1, 209524GR5, 209577RAD3, 209848OVRAD2, AVHRD22776, 510437PROT1, 510437PROT3, 805PIXRA, 818360XR1, 916536PRO1, 916575PROMN, 916LAGPRO1, 530528PROT, 530225PROT, 909788R2, 951552PROT, 909788R1, 310303WDR1, 916781PRO, 916781PROT2, 916784PRO, 916781PRER2, 916781PROT1, 916874PRO1, 916874PRO3, 916874PRO4, 831424RAD1, 209754RAD1, 818365RAD1, 415353SPIN1, 415750PROT1, 408559RAD12, 408885EDB, 408885VHC1, 408885VSC2, 408885VSC3, 408885EDA, 408885TUL, 510667PROTEUS, 510231PRO, 805563RAD1, 805681ORTHO, 805681RAD2, 805681RAD3, 805681RAD4, 805681RAD5, 310582WDR1, 562493RM1, 209943SJRM2, 408885SVC, 805418XR1, 310257PRO, 209832RAD1, 209835RAD1, 209835RAD2, 707TRAVISPRO, 209664ER1, 209664RAD3, 707429NBGV1, 707554ERRAD, 707554PROT1, 805648OPXR, 805648OPXR2, 805652ER, 805652WDR1, 760241RAD1, 925210RAD1, 818676ER, 818676PROT1, 818884ER, 530662PRO2, 530662PRO, 818610DR, 719SLVXR1, 719SLVXR2, 303AFCXR, 303FCBMOPTIMA, 970453XR1, 970945CARB, 541276AOPROTEUS, 719638RAD, 719487RAD, 970565RAD1, 303307GVRXR, 303320RAD1, 303563XR, 303DHXR1, 615812PROT, 303673XRGS1, 970479XR2,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- China
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