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
FDA Recall Z-2440-2019 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2019-07-25
Date Terminated2022-12-29
Product Quantity2867 units worldwide (OUS); 1464 units US
Reason for Recall
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 rescans
Firm Action
Siemens issued notification Urgent Medical Device Correction letter on 7/25/19 issued via electronic mail to consignees or by USPS certified mail if a consignee email address was not available. Letter states problem, health risk, action to take:
The remote software update installation process will require approximately 30 minutes for completion. The process is completely automatic; make sure the system and power are stable before and during the process and do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled.
If your system is connected to Siemens Remote Connection, this update will be performed remotely. Following the corrective action, the cause will be eliminated and a recurrence of the identified issues is prevented. If you have any questions, please contact our service organization at 1-800-888-7436.
Root Cause
Software design
Distribution Pattern
Nationwide Foreign:
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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