Recall Z-2992-2018— Hitachi Healthcare Americas Corp Informatics Division
Class II · Terminated
Class II FDA medical device recall by Hitachi Healthcare Americas Corp Informatics Division, initiated 2018-08-28, terminated 2021-02-11. It names one FDA 510(k) clearance: K083910. Product: VidiStar(TM) PACS & DICOM Viewer Software system. Reason: 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..
- Recalling firm
- Hitachi Healthcare Americas Corp Informatics Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-28
- Terminated
- 2021-02-11
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.