ClearCanvas RIS/PACS
Reported: April 29, 2020 Initiated: February 26, 2020 #Z-1758-2020
Product Description
ClearCanvas RIS/PACS
Reason for Recall
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Details
- Recalling Firm
- Synaptive Medical Inc
- Units Affected
- 903 units
- Distribution
- US
- Location
- Toronto, N/A
Frequently Asked Questions
What product was recalled? ▼
ClearCanvas RIS/PACS. Recalled by Synaptive Medical Inc. Units affected: 903 units.
Why was this product recalled? ▼
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1758-2020.
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