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