VidiStar(TM) PACS & DICOM Viewer Software system recall: Software Issue
VidiStar(TM) PACS & DICOM Viewer Software system
Why was VidiStar(TM) PACS & DICOM Viewer Software system recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
versions 3.10.5 and 3.10.6
- Product
- VidiStar(TM) PACS & DICOM Viewer Software system
- Recalling firm
- Hitachi Healthcare Americas Corp Informatics Division
- Quantity
- 12 units
- Distribution
- SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
- Recall date
- September 12, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)