FDAFDA · Food and drugs·Recall number Z-1758-2020
ClearCanvas RIS/PACS
Published April 29, 2020 · Recall initiated: February 26, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synaptive Medical Inc
- Distributor
- US
- Lot
- ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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