Recall – CT scan error may result in delay of diagnosis

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 9/11/2019
Class II

PRODUCT

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603

  • Recall Number: Z-2440-2019

REASON

SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient re-scans.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 7/25/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2867 units worldwide (OUS); 1464 units US

DISTRIBUTION

US Nationwide and International

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Partners located in the US (CA, FL, MA, MN) and Italy.