FDAFDA · Food and drugs·Recall number Z-2992-2018
VidiStar(TM) PACS & DICOM Viewer Software system
Published September 12, 2018 · Recall initiated: August 28, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Hitachi Healthcare Americas Corp Informatics Division
- Distributor
- SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
- Lot
- versions 3.10.5 and 3.10.6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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