Z-2992-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- August 28, 2018
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
VidiStar(TM) PACS & DICOM Viewer Software system
Reason for Recall
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.
Distribution Pattern
SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
Code Information
versions 3.10.5 and 3.10.6