Class II — Siemens Medical Solutions USA, Inc.
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The terminals on the plug may become loose and overheat. |
| 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. |
| Quantity | 78 units |
| 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, Net… |
| Initiated | 2018-09-28 |
| Classified | 2018-10-18 |
| Terminated | 2021-02-11 |
| Recall number | Z-0177-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc. (Z-0177-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81144/
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