The Recall Desk
ModerateFDA (Devices)·Z-0524-2018·Announced 2018-02-14

Siemens Syngo.plaza PACS Software Recall for Workflow Display Error

Siemens is recalling 76 Syngo.plaza systems with SW VB20A because prior studies may not replace correctly in all workflow steps, potentially showing outdated images.

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 the source text describes a software display error without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 76 Syngo.plaza systems equipped with software version VB20A (Model Numbers 10863171, 10863172, and 10863173). The affected systems are Picture Archiving and Communication Systems (PACS) used to display, process, and store digital medical images to support physician diagnosis and treatment planning.

The recall is due to a software defect where, in certain scenarios based on Display Protocol configuration, a prior study being replaced in a workflow step is only replaced in the active step. Consequently, other workflow steps may continue to display the initially loaded study rather than the updated one.

The affected units were distributed nationwide in the United States. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue.

The recalled product

Product
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: 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 s
Affected units
76

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 (3)

  • Model Number - 10863171
  • 10863172
  • 10863173

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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