# FDA recall Z-1748-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2017-11-08.

## Product

SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system

## Reason for recall

There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.

## Distribution

Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.

## Key facts

- **Recall number:** Z-1748-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-08
- **Report date:** 2018-05-23
- **Termination date:** 2023-05-18

- **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-1748-2018

## Citation

> AI Analytics. FDA recall Z-1748-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1748-2018. Source: US FDA. Licensed CC0.

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