# FDA recall Z-1261-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-01-10.

## Product

Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.

## Reason for recall

When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived".  This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function,  disc capacity for free space decreases faster than  usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.

## Distribution

Medical device software which needs to be installed.

## Key facts

- **Recall number:** Z-1261-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-10
- **Report date:** 2018-04-04
- **Termination date:** 2018-10-02

- **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-1261-2018

## Citation

> AI Analytics. FDA recall Z-1261-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1261-2018. Source: US FDA. Licensed CC0.

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