Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2793-2016·Announced 2016-09-21

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.

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. 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
Category: Medical Device — Imaging Software
Hazard: mis-labeling
measurement-error
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.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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