Recall – Computed tomography system software errors lead to scan abort

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 8/21/2019
Class II

PRODUCT

SOMATOM Definition AS, Model Number 8098027 – Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

  • Recall Number: Z-2268-2019
  • Recall Number: Z-2269-2019
  • Recall Number: Z-2270-2019
  • Recall Number: Z-2271-2019
  • Recall Number: Z-2272-2019
  • Recall Number: Z-2273-2019
  • Recall Number: Z-2274-2019

REASON

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 7/3/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

 

DISTRIBUTION

US Nationwide

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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