Z-0271-2010

Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression

Name: Z-0271-2010 Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-09-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-09-29 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression on 2009-09-29. The reason FDA records is "Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or...". 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-0271-2010
Status: Terminated
Initiated: 2009-09-29
Posted: 2009-11-16
Terminated: 2012-07-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.
Quantity in commerce: 30 units
Distribution: The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV.
Product codes and lots: Model number 10496279 - Serial numbers: 1088, 1089, 1150, 1165, 1166, 1213, 1214, 1344, 1361, 1371, 1372, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1395, 1413, 1418, 1424, 1425, 1453, 1496, and 1497.

Product code LLZ

K082430Class IISyngo Imaging XsSiemens AG Medical Solutions / cleared 2008-11-14

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)