Biograph Horizon a) 3R — Class II medical device recall Z-0177-2019

Terminated recall by Siemens Medical Solutions USA, Inc., reported 2018-10-24, distributed nationwide. The terminals on the plug may become loose and overheat.

Recall number	`Z-0177-2019`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, United States
Recall initiated	2018-09-28
Classified	2018-10-18
Reported by FDA	2018-10-24
Terminated	2021-02-11
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IT, JO, JP, KR, LB, LK, MX, MY, NL, NO, NZ, OM, PL, PT, PY, QA, RO, SA, SG, SI, SK, TH, TR, TW, VN, ZA
Quantity	78 units
Reason classes	device malfunction
Serial numbers	`94401`, `94402`, `94404`, `94405`, `94406`, `94407`, `94408`, `94409`, `94410`, `94411`, `94412`, `94413`, `94414`, `94415`, `94416`, `94417`, `94418`, `94419`, `94420`, `94421`, `94422`, `94423`, `94424`, `94425`, `94426` and 52 more

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0177-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.