Z-2992-2018 Class II Terminated
FDA device recall Z-2992-2018 was initiated by Hitachi Healthcare Americas Corp Informatics Division on August 28, 2018 and is designated Class II. 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. The recall status is terminated (terminated February 11, 2021). Affected quantity: 12 units.
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