Siemens syngo.plaza image processing system image processing radiological system
FDA Recall Z-0271-2014 · Posted 2013-11-13
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-08-08
Date Terminated2014-11-06
Product Quantity19
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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