Z-0271-2014Class II

Siemens syngo.plaza image processing system image processing radiological system

Name: Z-0271-2014 Siemens syngo.plaza image processing system image processing radiological system
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-08-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-08-08 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo.plaza image processing system image processing radiological system on 2011-08-08. FDA classified it as Class II and gives the reason as "The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who...". 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-0271-2014
Classification: Class II
Status: Terminated
Initiated: 2011-08-08
Posted: 2013-11-13
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo.plaza image processing system image processing radiological system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Safety Advisory Notice dated August 3, 2011, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to forward the Customer Safety Advisory Notice to their customers. If necessary, customers should have the letter translated technically into the local language and copy it themselves. A letter was sent to direct accounts to inform them of the issu and provide instructions to avoid encountering the problem. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 19
Distribution: Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.
Product codes and lots: Model Number 10592457 with serial numbers 100263, 100177, 100138, 100174, 100005, 100006, 100007, 100008, 100009, 100010, 100219, 100201, 100198, 100181, 100249, 100301, 100302, 100157, 100146

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0271-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0271-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13

Product code LLZ

K093612Class IISyngo.plazaSiemens AG Medical Solutions / cleared 2010-03-04

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)