Siemens Syngo Dynamics PACS Recalled for Patient Demographics Display Error
Siemens Medical Solutions is recalling 50 Syngo Dynamics v9.5 systems due to a software error that may cause incorrect patient demographics to be displayed.
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 device) where a software error may lead to incorrect patient data display, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 50 units of the Syngo Dynamics v9.5 system, a Picture Archiving and Communication System (PACS) used for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images. The affected units are identified by specific model numbers (10091805, 10091806, 10091807, 10091673) and a list of 50 serial numbers provided in the recall notice.
The recall is being conducted because the systems are experiencing a software error which may lead to the incorrect display of patient demographics. This issue could potentially impact the accuracy of patient information presented within the system.
The affected units were distributed nationwide in the United States, specifically in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, WA, WI, and WV. Healthcare facilities and users of these systems should verify their equipment against the provided serial numbers and contact Siemens Medical Solutions for further instructions on remediation.
The recalled product
- Product
- Syngo Dynamics v9.5 system. 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.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — PACS
- Affected units
- 50
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 (3)
- model numbers: 10091805
- 10091806
- 10091807
Distribution
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