Devices

Device Recall Ventana Image Analysis System (VIAS)

Model / Serial
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
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
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
- Recall of Device Recall Ventana Image Analysis System (VIAS)

Manufacturer

Ventana Medical Systems Inc

Manufacturer Address
Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
Manufacturer Parent Company (2017)
Roche Holding Ag
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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