PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 21, 2014 Initiated: April 3, 2014 #Z-1613-2014

Product Description

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.

Reason for Recall

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

Details

Units Affected
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.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 50.
Why was this product recalled?
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 21, 2014. Severity: Moderate. Recall number: Z-1613-2014.