Siemens syngo.plaza image processing system image processing radiological system

FDA device recall Z-0271-2014 · posted 2013-11-13 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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.

Action taken

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

Status

Terminated

Product code

LLZ

Quantity affected

19

Distribution

Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.

Date initiated

2011-08-08

Date posted

2013-11-13

Date terminated

2014-11-06

Location

Malvern, PA

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