# FDA recall Z-0178-2019

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

## Product

Biograph mCT:  a) S(64)-3R, Material Number 10248669  b) S (20) -3R, Material Number 10507786  c)  Flow 20-4R, Material Number 10528958  d) m Flow 64-4R, Material Number 10529161  e)  mCT S(40)-4R, Material Number 10248671  f)  mCT S(64)-4R, Material Number  0248672  g)  mCT S(20)-3R, Material Number 10534159  h)  mCT Flow Edge-4R, Material Number 10528955  i)  mCT Flow 40-3R, Material Number 10529158  j)  mCT Flow 64-3R, Material Number 	10529160  k)  mCT X-4R, Material Number 10248670  l)  mCT X-3R, Material Number 10248673  m)  mCT S(20)-4R, Material Number 10534160  n)  mCT S(40)-3R, Material Number 10248668  o)  mCT Flow 40-4R, Material Number 10529159  p)  mCT Flow 20-3R, Material Number 10528956  q)  mCT Flow Edge-3R, Material Number 10528954    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 informatio

## 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-0178-2019
- **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-0178-2019

## Citation

> AI Analytics. FDA recall Z-0178-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0178-2019. Source: US FDA. Licensed CC0.

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