FDAFDA · Alimentos y medicamentos·N.º oficial Z-0068-2026
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Publicado el 15 de octubre de 2025 · Inicio del retiro: 5 de septiembre de 2025
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
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Medical Systems, SCS
- Distribuidor
- Domestic US distribution nationwide. International distribution worldwide.
- Lote
- UDI-DI 00840682102384 System IDs 907729AWS1 720238AW1 907ULMCCT 205934AWSRV 205975AWSRV 205971AWS 205510VAW 205815AWS2 UABMAWS1 749153GE3 UABMRPET 256593AW1 256265AWS4 256265AWS3 205481AWS1 251343AWS 251665MCIAWS 251316VAWS 251435AW5 251435AWSMARTSUB1 303584HP To be provided 251435AWSSMARTSUB1 256386AW1 205RCAWS 870423AWSMARTSUB1 870642AWS 718329SMART11 479314AWS1 479314AWS2 870207AW1 501686AWS31 501978AW1 501686AWSMARTSUB2 501552AW2 501202AWS1 501686AWSMARTSUB1 479338AWS 928773AWS 928214AWS 480256AWS 928757AWEN To be provided pacsaws01 To be provided 602344AWS 602651AWS 480342AWS 602277REVAW 480342AWSMARTSUB2 480342AWSMART1 480342AWSMART2 602344AWS1 602344SMARTAW 480342AWS2 602BUMC870 480342AWSMARTSUB3 928445AW1 06A6A668-AW-AWS_PRIMARY 844823AW1 844823AW 928283AWSMARTSUB1 520STJAWS 818RIAWSVR 661CHAWS 661KMCAWS 13123 13767 650696AWS To be provided 530UCVETAWSERV To be provided 760633HDCT To be provided 714FVAWSERVER 714FVDISC 510792AWH 559326AWS1 714447AWS AVHHFCTAW1 858657AWSMARTSUB2 858626AWS32 858824AWSMARTSUB2 858824SMARTSUB1 To be provided 909558SMART 805737AW2 562826AW46 9694 9693 323361AWSMARTSUB1 13256B To be provided 13526B 559353AW1 949367AWS 323BEVAWS 951704AWS 949764AWS 949764SMARTAW 510534AWS 510869AWSERV 510752AWS 916SUTABAWS 510437AWDL360 5496962AW11 510869APEX 760940AWS32 760940APEX 714771AWSRV 714456AWSMART 714456AW 650725AWS10 650725AWS30 650725AWSVM1 650725AWSVM2 650725AWSVM3 808341AW2 760446AWS 949278AW2 916SUTAWS 916SUTAWS2 916UCDAWS To be provided 858966SERVER 619532SERVER 9907 858657AWS32 858939EHLAWS 858626EHLAWS 858805AWSVM01 415600AWSERVER 415833AWSF 415476AWV 415MBCREV1 UCSFAWS4 UCSFAWS3 650725AWS20 408GSHOGEAW 408259EDCT 510784AWSERVER 9200 13195B 13196B 650696PET 805AWVM 310264AWS SHCGEAWSVM2 To be provided 818881AWSVR 805434AWS AWSHT1 310222HPAW 310823EHL1 310423EHL2 310423EHL1 To be provided 818782AWS1 To be provided 818676AW4 310423AWS 310423AWS2 To be provided 970544AWS 720848AWSRV 719365AWS DHAWSERV1 MCAAWSERV 303602AWS1 303DHREVCT 970945AWL03 970945VAW 307FRMIPCT4 719955REVO1 303603AWSRV 720321AWS1 303730AW 719584VPSW 203384AWSERVER 203739AWS 860679AWS 860679AWSSCT To be provided 860JRAWS 860972AWSMARTSUB2 203694AWSMARTSUB1 203694RTCT16 203694CTREV 860344CTFR1AW 860358AW1 To be provided 860224AWSVR1 860224EDAWSSCT 860224APEXAWSSCT 203737AWSVR 203276AWS1 203380AW1 860496AW02 203261AWS 860456APEXAWSSCT 202715AWS 202476AWS 202877AWS32 202745CT1 To be provided 302744AW 302744AWSMART 302645AWS1 302733AWSERVERL02 302733AWSMARTSUB2 To be provided 302645AWS DUPONTPETMRAW 732996AW1 727398AWS2 727398AWS 561955AWS1 561955SMARTSUBAWS1 561955AW2 954450AWS 561955SMARTSUBEVO1 561736AWS To be provided BRANDONAWS To be provided 352799AWLOW 352597AWS2 813635MPAWS 321799CTT03 321799AWS 314868AWS1 386HAWSERVER2 AM1436W320_DUP To be provided RADIOLOGY20072529AWS 772LMCAWS 850863AW1 352376AW 333SERV MEMAWSERVER MEMAWS 786243AWS1 BAYONETPTAWS To be provided 904202VAWS 904953AWS2 904953AWS 904202AWS 904953AWS3 904244AWS1 904ASHCHIVAWS 904996VAWS AM13D0X149_DUP 561747AW49 OSCAWSERVER 407PCSERVER 863577MRAW WATSONAWS2 321HFSERV To be provided 305575AWS 305596AWS 786596AWS 786596AWS1 305223AWS 305575REVO 786596WKSMART To be provided To be provided To be provided To be provided To be provided HCIT5218773AWS 305535AWSR NCHAWSERV NCHAWSERV2 239NHAWSERV USONCAWSRV 352816AW 850383AWE2 850383AWE1 OVAWSERVER 561346AW 386TLSERVER 954844AWSMARTSUB1 850494CTAWSER 941883AWSERV 772335AWV AM141C095 To be provided 904819AWS 407321AWL02 FAWCETTAWS LARKINAWS32 305284EVO To be provided 850431AWSERVER 813635AWSRV MACDILLAWS BAYCAREAWS1 BAYCAREAWS2 MOFFITTAWS2 954767AWE2 954767AWE1 AM15P4F42_DUP HLEEMOFF20867329 561969AWS1 404616AWLTSERVER 770903AW3 404686AWSMART 404686REV80AWS 404616AWSMART2 404616REV_ES_AWEHL 404616AWS 404616AWSMARTSUB2 404616CASSAPEX2EHLAWS 404616CASSAPEX To be provided 404686APEX_EHL_AWS 404686REV_80_AWS 706774AWSER 912466OAW 912466AWS 770812HP 706544MAAWS 706787AWSERV 706787PCT To be provided 770219AW1 770535REV 4
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- France
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