# FDA recall Z-1930-2018

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2018-02-21.

## Product

Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.

## Reason for recall

Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.

## Distribution

Domestic distribution to .      International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.

## Key facts

- **Recall number:** Z-1930-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-21
- **Report date:** 2018-05-30
- **Termination date:** 2018-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hoffman Estates, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2018

## Citation

> AI Analytics. FDA recall Z-1930-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1930-2018. Source: US FDA. Licensed CC0.

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