Siemens Syngo Dynamics PACS Software Recall for Measurement Package Issue
Siemens is recalling Syngo Dynamics PACS software due to a potential issue in the VA10 measurement package. 228 units are affected nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Siemens Syngo Dynamics Picture Archiving and Communication System (PACS) software. The recall involves specific model numbers (10091805, 10091807, 10091637, 10091673) and is due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
The affected software is intended for the acceptance, transfer, display, storage, and manipulation of digital medical images, including quantification and report generation. It is not intended for the reading of mammography images. A total of 228 units are involved in this recall.
The recall covers units distributed nationwide in the United States, including states such as 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, and NM. The source text does not specify reported injuries, illnesses, or specific corrective actions for consumers beyond the recall notice.
The recalled product
- 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 i
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 228
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial #: 85170
- 85175
- 85346
- 85362
- 85082
- 85083
- 85450
- 85479
- 85035
- 85476
- 85358
- 8 4184
- 85191
- 85377
- 8 5387
- 85903
- 85487
- 85060
- 85415
- 85857
Distribution
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