—#114137

Product

Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing 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 10 592 457

Why it was recalled

Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could

Root cause (FDA determination)

Software design

Action the firm took

The firm, Siemens, sent "Update Instruction SY050/12/S" on June 20, 2012 to its consignees/customers. The Update Instructions described the product, problem and actions to be taken. It also provides a software update. If you have any questions call 610-219-4834 or email: anastasia.mason@siemens.com.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.

Timeline

Recall initiated: 2012-06-20
Posted by FDA: 2012-12-03
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114137. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.