FDAClass IIMay 21, 2014

Syngo Dynamics v9.5 system. A Picture Archiving and recall: Software Issue

Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and…

Why was Syngo Dynamics v9.5 system. A Picture Archiving and recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
50
Distribution
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.
Recall date
May 21, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls