Siemens Syngo Plaza PACS Recall for Measurement Display Suffix
Siemens is recalling 101 Syngo Plaza PACS systems because a suffix on DICOM images may indicate that displayed measurements differ from actual values.
What this means for you
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. The hazard involves potential measurement inaccuracy in medical imaging, which is a significant issue but does not involve direct physical injury or death, fitting the Moderate severity criteria for labeling/display errors.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 101 units of the Syngo Plaza picture archiving and communication system (PACS). These systems are intended to display, process, read, report, communicate, distribute, store, and archive digital medical images. The recall is due to a Customer Advisory Notice explaining the meaning of a suffix "o.p." that appears on some DICOM images for area, distance, or perimeter values.
The suffix "o.p." stands for "on projection" and indicates that the displayed measurement value may be different from the real value. This issue affects the accuracy of measurements shown on the system. The affected units were distributed nationwide.
Healthcare facilities using these systems should be aware that measurement values with the "o.p." suffix may not reflect the true physical dimensions. Siemens is releasing this notice to clarify the meaning of the suffix to ensure proper interpretation of the displayed data.
The recalled product
- Product
- Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 101
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 (20)
- Model Numbers: 10863171
- 10863172
- 10863173
- 10592457 Serial Numbers: 100262
- 100389
- 100198
- 100258
- 100259
- 100538
- 100135
- 100133
- 100213
- 100214
- 100031
- 100032
- 100484
- 100362
- 100233
- 100140
- 100141
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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