—#126665

Product

Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023772, K102150
Affected lot / code info: model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170 85250 85188 85191 85198 85151 85165 85241 85130 85163 85019 85287 85298 85202 85168 85068 85206 85280 85235 85195 85194 85123 85199 85364 85282 85275 85115 85062 85067 85080 85216 85218 85177 85242 85248 85237 85284 85329 85259 85279 85230 85192 85277 85278 85178 85220 85157 85114 85268 85134

Why it was recalled

Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.

Timeline

Recall initiated: 2014-04-03
Posted by FDA: 2014-05-13
Terminated: 2014-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126665. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.