Z-0324-2009

syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for...

Name: Z-0324-2009 syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-09-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-09-12 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system on 2008-09-12. The reason FDA records is "Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected". 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-0324-2009
Status: Terminated
Initiated: 2008-09-12
Posted: 2008-12-03
Terminated: 2009-09-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.
Quantity in commerce: 130 units
Distribution: Nationwide Distribution.
Product codes and lots: Serial numbers: 7826, 7951, 7981, 7989, 8011, 8056, 8109, 8161, 8209, 8213, 8312, 8341, 8361, 8382, 8393, 8405, 8409, 8413, 8430, 8433, 8442, 8511, 8526, 8536, 8548, 8637, 8638, 8657, 8670, 8688, 8701, 8707, 8771, 8772, 8773, 8774, 8781, 8793, 8814, 8829, 8862, 8879, 8881, 9043, 9044, 9046, 9080, 9097, 9081, 9105, 9137, 9149, 9152, 9154, 9188, 9191, 9206, 9218, 9219, 9232, 9235, 9243, 9244, 9248, 9283, 9291, 9316, 9322, 9351, 9360, 9361, 9368, 9388, 9394, 9395, 9413, 9414, 9416, 9417, 9429, 9445, 9446, 9452, 9488, 9498, 9504, 9508, 9520, 9521, 9532, 9536, 9568, 9723, 9725, 9729, 9737, 15154, 15510, 15512, 20903, 20904, 20907, 20917, 20928, 20931, 20937, 20939, 20940, 20941, 20942, 20943, 20944, 20945, 20946, 20948, 20955, 20956, 20957, 20961, 20962, 20972, 20974, 20977, 21017, 21018, 21020, 21021, 21025, 21028, and 21030.

Product code LLZ

K010938Class IISyngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. / cleared 2001-06-26

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)