# FDA recall Z-0524-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2017-08-23.

## 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 supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

## Reason for recall

When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0524-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-23
- **Report date:** 2018-02-14
- **Termination date:** 2018-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2018

## Citation

> AI Analytics. FDA recall Z-0524-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0524-2018. Source: US FDA. Licensed CC0.

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