Biograph mCT: a) S — Class II medical device recall Z-0178-2019
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-0178-2019 |
|---|---|
| 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 | 890 units |
| Reason classes | device malfunction |
| Serial numbers | 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1022, 1023, 1024, 1025, 11001 and 313 more |
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 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-0178-2019. 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.