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Devices
Device Recall Ventana Image Analysis System (VIAS)
모델명 / 제조번호(시리얼번호)
Serial Numbers: HIS06086 HIS05042 HIS06047 HIS05018 HIS05022 HIS06046 HIS06092 HIS06059 HIS06053 HIS05053 HIS06035 HIS06038 HIS05026 HIS06100 HIS06021 HIS06074 HIS05041 HIS05017 HIS06031 HIS05051 HIS06061 HIS06028 HIS05011 HIS06083 HIS06064 HIS06057 HIS06055 HIS05047 HIS05012 HIS06054 HIS06073 HIS06088 HIS06076 HIS06002 HIS06001 HIS06004 HIS06034 HIS06015 HIS06098 HIS06069 HIS05044 HIS06033 HIS06050 HIS05046 HIS06030 HIS06095 HIS06067 HIS05028 HIS06027 HIS06056 HIS05033 HIS06049 HIS06026 HIS06008 HIS05049 HIS05013 HIS06079 HIS06072 HIS06089 HIS06084 HIS06044 HIS06007 HIS05027 HIS06051 HIS06052 HIS05025 HIS06096 HIS06066 HIS06039 HIS06065 HIS06019 HIS05052 HIS06029 HIS06022 HIS06068 HIS05048, and HIS05058
의료기기 분류등급
Hematology and Pathology Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationwide and Canada
제품 설명
Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755
Manufacturer
Ventana Medical Systems Inc
1 Event
Device Recall Ventana Image Analysis System (VIAS) 의 리콜
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제조사
Ventana Medical Systems Inc
제조사 주소
Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
제조사 모회사 (2017)
Roche Holding Ag
Source
USFDA
Language
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