Recall – Diagnostic image quality negatively affected by software defect

Company: Synaptive Medical Inc.
Date of Enforcement Report: 4/29/2020
Class II

PRODUCT

ClearCanvas RIS/PACS

Recall Number: Z-1758-2020

REASON

A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

RECALLING FIRM/MANUFACTURER

Synaptive Medical Inc. on 2/26/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

903 units

DISTRIBUTION

US Nationwide

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.