Z-0732-2008

Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical...

Name: Z-0732-2008 Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-11-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-11-27 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355 on 2007-11-27. The reason FDA records is "Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)". 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-0732-2008
Status: Terminated
Initiated: 2007-11-27
Posted: 2008-02-23
Terminated: 2008-09-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released.
Quantity in commerce: 10 units
Distribution: Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.
Product codes and lots: Serial Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and 1282.

Product code LLZ

K071114Class IISyngo Imaging (Version V30)Siemens AG Medical Solutions / cleared 2007-05-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)