Synaptive Medical Recalls ClearCanvas RIS/PACS Software Due to Imaging Defect
Synaptive Medical is recalling ClearCanvas RIS/PACS software because a defect affects mammogram image quality, potentially leading to misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical imaging software) where injury or misdiagnosis has not yet been reported, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Synaptive Medical Inc is recalling 903 units of ClearCanvas RIS/PACS software. The recall involves part number SYN-0524 with versions 3.0 and higher, distributed in the United States.
The recall is due to a software defect that negatively affects the quality of images taken during diagnostic imaging, specifically mammograms. This defect may result in misdiagnosis of patients.
Healthcare facilities and users of the affected software should contact Synaptive Medical Inc for further instructions on how to address the defect.
The recalled product
- Product
- ClearCanvas RIS/PACS
- Manufacturer
- Synaptive Medical Inc
- Category
- Medical Device — Software
- Affected units
- 903
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ClearCanvas RIS/PACS
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Synaptive Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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