# FDA recall Z-1699-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-02-20.

## Product

Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173    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

Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.

## Distribution

USA (nationwide)

## Key facts

- **Recall number:** Z-1699-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-20
- **Report date:** 2018-05-16
- **Termination date:** 2019-07-16

- **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-1699-2018

## Citation

> AI Analytics. FDA recall Z-1699-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1699-2018. Source: US FDA. Licensed CC0.

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