—#175606

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

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143400, K143401, K190578
Affected lot / code info: syngo.CT software version VA48A_SP5.5

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide Foreign:

Timeline

Recall initiated: 2019-07-25
Terminated: 2022-12-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175606. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.