# FDA recall Z-0405-2018

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2017-07-25.

## Product

Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.  It supports the physician in diagnosis and treatment planning.

## Reason for recall

Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

## Distribution

USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.

## Key facts

- **Recall number:** Z-0405-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-25
- **Report date:** 2018-01-31
- **Termination date:** 2018-07-23

- **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-0405-2018

## Citation

> AI Analytics. FDA recall Z-0405-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0405-2018. Source: US FDA. Licensed CC0.

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