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.
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
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.
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.
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.
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.
Verify your ClearCanvas RIS/PACS software version to ensure it is 3.0 or higher.
The recall affects healthcare providers using the software, but patients may be impacted if their imaging is misdiagnosed due to poor image quality.
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.
Look for model number SYN-0524 with software versions 3.0 or higher, and check the Unique Device Identifier (UDI) code (01)00670082000115 (10)1x1.
We’ve drafted a message you can send Synaptive Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1758-2020 — Synaptive Medical Synaptive Medical Hello, I own a Synaptive Medical that is covered by recall Z-1758-2020 from Synaptive Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
