Siemens syngo.plaza Mammography Software Recall for Image Alignment Issues
Siemens is recalling syngo.plaza software due to potential issues with mammography image laterality and alignment.
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, and the source text describes a potential software display and alignment issue without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity, representing a risk of harm where injury has not yet been reported but is not a critical life-threatening defect.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling six units of syngo.plaza software version VA20 with Mammography license. The recall is due to a potential problem where laterality information in mammography images may not be displayed, and the images may not be properly aligned to mammography segments.
The affected software is distributed nationwide in Florida, Massachusetts, Kansas, New York, Ohio, Pennsylvania, Texas, and Wisconsin. The specific model number is 10592457, and the affected serial numbers include 100219, 100201, 100473, 100177, 100504, 100174, 100181, and 100539.
Siemens issued a Customer Safety Notice to inform customers of this potential problem. Users should contact Siemens for further instructions on how to address the issue.
The recalled product
- Product
- Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 6
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 (8)
- Model number 10592457
- serial numbers 100219
- 100201
- 100504
- 100174
- 100181
- 100473
- and 100539.
Distribution
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSiemens syngo.plaza Radiological Image Processing System Recalled for Malfunction
FDA (Devices) · 2012-08-01
- ModerateSiemens Syngo.plaza PACS Software Recall for Workflow Display Error
FDA (Devices) · 2018-02-14
- ModerateSiemens syngo.plaza Radiological Image Processing System Recalled for Miscalculation
FDA (Devices) · 2012-09-05
- HighSiemens Syngo.plaza PACS Software Recalled for Data Security and Integrity Issues
FDA (Devices) · 2018-02-07
- HighSiemens Medical Solutions Recalls Syngo.plaza PACS Software for Print Size Errors
FDA (Devices) · 2014-12-17
- ModerateSiemens syngo.plaza Radiological Image Processing System Software Update Recall
FDA (Devices) · 2012-12-12