Siemens syngo WorkFlow SLR Recall for Patient Data Display Error
Siemens Medical Solutions is recalling syngo WorkFlow SLR software due to a defect that may display the wrong patient's documents in signed reports.
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 software) where a data integrity error could lead to incorrect patient information, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 37 units of the syngo WorkFlow SLR Radiological Information System, software versions VA31A SP1, SP2, and SP3. The affected model numbers are 10558922, 10558933, and 10558980. The product is a digital radiology information system used for patient administration, examination, and reporting, and it does not have direct contact with patients.
The recall is due to a software defect in the Search functionality. Under certain conditions, the system may display the wrong patient's Interactive Documents when a user views a signed report in the single patient view. This error can occur if an Interactive Document is viewed or auto-displayed, dismissed by the user, and then a different patient and signed exam are selected.
The affected units were distributed worldwide, including in the United States (specifically in AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY), Canada, and Australia. Users of the affected software should contact Siemens Medical Solutions USA, Inc. for information on corrective actions.
The recalled product
- Product
- Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 37
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 (2)
- Model numbers 10558922
- 10558933 and 10558980 with software version VA31A SP1/SP2/SP3
Distribution
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