# FDA recall Z-0177-2019

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2018-09-28.

## Product

Biograph Horizon  a) 3R, Material Number 10532746  b) 4R, Material Number 10532748    The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

## Reason for recall

The terminals on the plug may become loose and overheat.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Brunnel, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel,  Italy, Japan, Jordan, Republic Korea, Lebanon, Sri Lanka, Macedonia, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, Switzerland, Thailand, Turkey, Taiwan, UAE, United Kingdom and Vietnam.

## Key facts

- **Recall number:** Z-0177-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-28
- **Report date:** 2018-10-24
- **Termination date:** 2021-02-11

- **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-0177-2019

## Citation

> AI Analytics. FDA recall Z-0177-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0177-2019. Source: US FDA. Licensed CC0.

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