Siemens Syngo Dynamics Software Recalled for Potential Patient Data Mixing
Siemens is recalling Syngo Dynamics PACS software because it may mix data from multiple patients in echo trend graphs.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 151 units of Syngo Dynamics software, a Picture Archiving and Communication System (PACS) used for digital medical images. The recall is due to a software issue that can cause echo trend graphs to mix data from multiple patients in rare situations.
The affected software, model #10091673, was distributed nationwide in the United States, including in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
Siemens is releasing a software update to address the issue. Users should contact Siemens to obtain the update. The software is not intended for reading mammography images.
The recalled product
- Product
- software for Syngo Dynamics 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. Syngo Dynamics is not intended to be used…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 151
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 (1)
- For model #10091673
Distribution
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