Siemens syngo Dynamics Version 9.5 Recalled for Potential Image Misplacement
Siemens Medical Solutions is recalling syngo Dynamics Version 9.5 because images from one patient may be placed in another patient's study.
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 imaging software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions, USA, Inc. is recalling 30 units of syngo Dynamics Version 9.5. The recall is due to a software issue where, if multiple uncompressed images or clips are sent to the server around the same time, an image from one patient may be placed in another patient's study.
The affected software was distributed nationwide to facilities in Massachusetts, Georgia, Missouri, Iowa, California, Pennsylvania, Oregon, Colorado, New York, New Jersey, Washington, Utah, Ohio, Wisconsin, Michigan, Kentucky, and North Carolina. The specific codes associated with the recall are 10091862 and 10091863.
Consumers and healthcare facilities should contact Siemens Medical Solutions for further instructions on how to address this issue.
The recalled product
- Product
- syngo Dynamics Version 9.5
- Manufacturer
- Siemens Medical Solutions, USA, Inc
- Category
- Medical Device — Software
- Affected units
- 30
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)
- 10091862 and 10091863
Distribution
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