—#105378

Product

syngo Imaging XS, all versions Radiological image processing system

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082430
Affected lot / code info: Model number 10496279

Why it was recalled

Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.

Timeline

Recall initiated: 2011-09-20
Posted by FDA: 2012-01-11
Terminated: 2014-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105378. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.