Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1183-2016·Announced 2016-03-23

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Software
Hazard: software-defect
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

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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