Reported Sep 12, 2018 · Terminated
VidiStar(TM) PACS & DICOM Viewer Software system
Hitachi Healthcare Americas Corp. Informatics Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Healthcare Americas Corp Informatics Division · 204 Westfield St · Greenville, SC · 29601-1833
Is this the product you have?
- VidiStar(TM) PACS & DICOM Viewer Software system
- Lot codes and dates
- versions 3.10.5 and 3.10.6
- Amount recalled
- 12 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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