The Recall Desk
HighFDA (Devices)·Z-1758-2020·Announced 2020-04-29

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.

What this means for you

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
Hazard
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.

See all 2 products in this recall →

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