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Siemens Medical Solutions USA, Inc recalls Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637,
Recalled March 23, 2016 · FDA recall Z-1183-2016 · Siemens Medical Solutions USA
Hazard
Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics. · FDA Class II
Units
228 units
Sold at
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.
Description
Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →