Siemens Medical Solutions USA, Inc recalls Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637,…

Recall date

January 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1183-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution including states of: MN, NC, NE, FL, TX, CA, AR, MI, MA, IL, DE, VA, SC, OH, CO, WI, MO, NY, CT, UT, PA, WA, NJ, GA, IN, MD, TN, LA, OR, AZ, ND, KS, AL, NM.

Why it was recalled

Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.