# FDA recall Z-0495-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2017-08-18.

## Product

Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173    Syngo.plaza is a Picture Archiving and Communication System (PACS) software device 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 update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.

## Distribution

USA (nationwide) Distribution to the states of :  AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI.     Foreign consignees were not reported as device is manufactured outside the U.S.

## Key facts

- **Recall number:** Z-0495-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-18
- **Report date:** 2018-02-07
- **Termination date:** 2018-08-30

- **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-0495-2018

## Citation

> AI Analytics. FDA recall Z-0495-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0495-2018. Source: US FDA. Licensed CC0.

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