The Recall Desk
ModerateFDA (Devices)·Z-1533-2017·Announced 2017-03-29

Siemens Syngo.plaza PACS Systems Recalled for Software Update Issues

Siemens Medical Solutions is recalling 13 Syngo.plaza PACS systems nationwide due to software update issues. The recall is voluntary and has been terminated.

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 and is a voluntary, firm-initiated action for software updates. The source text does not report any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is voluntarily recalling 13 units of the Syngo.plaza Picture Archiving and Communications System (PACS). The recall was initiated on February 20, 2017, and was terminated on August 7, 2017. The reason for the recall is cited as software updates.

The affected devices are distributed nationwide to Missouri, Texas, Florida, Massachusetts, Wisconsin, Pennsylvania, Indiana, and California. The specific model numbers are 10863171 and 10863173, with serial numbers ranging from 100212 to 100484 as listed in the recall documentation.

This recall is classified as Class II by the FDA. The firm notified customers via letter. No specific injuries or illnesses are reported in the source text.

The recalled product

Product
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosi
Affected units
13

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 (1)

  • Device Model Number: 10863171

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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