Synaptive ClearCanvas RIS/PACS Software Defect May Cause Misdiagnosis
Synaptive Medical recalls ClearCanvas RIS/PACS software versions 3.0+ due to image quality issues that could lead to misdiagnosis in mammograms. Affected units have specific model numbers and UDI codes.
Lower-risk recall
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Contact the company
What happened, in plain English
Synaptive Medical is recalling ClearCanvas RIS/PACS software versions : 3.0 and higher because a defect can cause poor image quality during mammograms, potentially leading to misdiagnosis. This affects healthcare providers using the system for diagnostic imaging. Read more at govinfonow.com/recall/65742-synaptive-clearcanvas-ris-pacs-software-defect-may-cause-misdiagnosis.
Source Summary by GovInfoNow · govinfonow.com/recall/65742-synaptive-clearcanvas-ris-pacs-software-defect-may-cause-misdiagnosis · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1758-2020
Cite this page
“Synaptive ClearCanvas RIS/PACS Software Defect May Cause Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65742-synaptive-clearcanvas-ris-pacs-software-defect-may-cause-misdiagnosis. Based on FDA recall #Z-1758-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1758-2020%22&limit=1).
Why it’s dangerous
The software defect causes image quality issues during diagnostic imaging, specifically mammograms. Poor image quality could lead to misdiagnosis if the images are not clear enough for accurate analysis by healthcare providers.
Who’s affected
Healthcare providers using ClearCanvas RIS/PACS software versions 3.0 and higher for diagnostic imaging, particularly those performing mammograms. Patients receiving imaging with affected systems may be at risk of misdiagnosis.
How to tell if you have this one
Check if your ClearCanvas RIS/PACS system has model number SYN-0524 with software versions 3.0 or higher. The Unique Device Identifier (UDI) code (01)00670082000115 (10)1x1 may also be present.
- Brand
Synaptive Medical- Product
ClearCanvas RIS/PACS- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1758-2020 | ClearCanvas RIS/PACS; ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1 | 903 units |
| Z-1759-2020 | Synaptive ImageDrive Clinical; ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1 | 28 units |
What to do — step by step
Check Software Version
Verify your ClearCanvas RIS/PACS software version to ensure it is 3.0 or higher.
How this recall unfolded
Recall timeline
FDA terminated this recall 4.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the affected software?
Check your software version and UDI code to confirm if you are affected; the recall does not require immediate action but should be addressed by the manufacturer.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1758-2020 (February 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1758-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.