—#120166

Product

Siemens syngo.plaza image processing system image processing radiological system

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093612
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

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

Timeline

Recall initiated: 2011-08-08
Posted by FDA: 2013-11-13
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120166. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.