Greenville, SC, United States
Hitachi Healthcare Americas Corp Informatics Division recalls
1 recall recorded since 2018, most recently on 28 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 August 2018
- Terminated
- 11 February 2021
- 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.
- Distribution
- SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2992-2018
- VidiStar(TM) PACS & DICOM Viewer Software system
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.