Z-2440-2019Class II

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition...

Name: Z-2440-2019 syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition...
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-07-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-07-25 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model... on 2019-07-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2440-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-25
Posted: 2019-08-30
Terminated: 2022-12-29
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: JAK System, X-Ray, Tomography, Computed
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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 2867 units worldwide (OUS); 1464 units US
Distribution: Nationwide Foreign:
Product codes and lots: syngo.CT software version VA48A_SP5.5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2440-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2440-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)