CLASS II Device recall · Reported 12 Sep 2018 · FDA Enforcement Report
VidiStar(TM) Pacs & Dicom Viewer recalled by Hitachi Healthcare Americas
Hitachi Healthcare Americas Corp Informatics Division is recalling VidiStar(TM) Pacs & Dicom Viewer, distributed in 10 states. The recall was initiated on 28 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2992-2018
- FDA event ID
- 80896
- Recalling firm
- Hitachi Healthcare Americas Corp Informatics Division, Greenville, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2018
- FDA classified
- 6 Sep 2018
- Reported
- 12 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 28 Aug 2018 | Recall initiated by company | |
| 6 Sep 2018 | Classified by FDA | +9 days |
| 12 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VidiStar(TM) PACS & DICOM Viewer Software system
Where it was distributed
SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
ArizonaColoradoGeorgiaIllinoisIndianaMassachusettsMontanaOhioSouth CarolinaTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
versions 3.10.5 and 3.10.6
Where was it sold?
SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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