Hitachi VidiStar PACS Software Recalled for Potential Image Mix-Up
Hitachi is recalling VidiStar PACS software versions 3.10.5 and 3.10.6 because a defect may cause images from multiple patients to appear in a single study.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to diagnostic errors by displaying images from multiple patients in a single study. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hitachi Healthcare Americas Corp Informatics Division is recalling 12 units of the VidiStar(TM) PACS & DICOM Viewer Software system, specifically versions 3.10.5 and 3.10.6. The recall is due to a defect in the secure filesystem client software used in the interface between the VidiStar PACS and an Electronic Health Record (EHR) system.
The identified issue may cause intermixed images from multiple patients to be displayed within a single study. This software defect poses a risk of diagnostic error or patient safety concerns due to the potential for viewing incorrect medical images.
The affected units were distributed to facilities in South Carolina, Colorado, Illinois, Arizona, Montana, Ohio, Indiana, Texas, Georgia, and Massachusetts. Healthcare facilities using this software should contact the manufacturer for instructions on how to resolve the issue.
The recalled product
- Product
- VidiStar(TM) PACS & DICOM Viewer Software system
- Category
- Medical Device — Software
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- versions 3.10.5 and 3.10.6
Distribution
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