Symbia E is a multi-purpose SPECT system ideal for hospitals and… — Class II medical device recall Z-0115-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2014-10-29, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.
| Recall number | Z-0115-2015 |
|---|---|
| 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 | 2013-10-28 |
| Classified | 2014-10-22 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2016-12-23 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, FI, FR, GB, GR, HK, HN, HR, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LK, LU, LV, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 562 devices |
| Serial numbers | 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1021, 1022, 1023, 1024, 1025 and 475 more |
| Model numbers | 10275879, 10413009 |
Product
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
Reason for recall
Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.
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-0115-2015. 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.