Siemens Intevo Series system — Class II medical device recall Z-2437-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-08-26, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo syst
| Recall number | Z-2437-2015 |
|---|---|
| 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 | 2015-07-31 |
| Classified | 2015-08-20 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-12-23 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, HK, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KR, KW, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 185 |
| Reason classes | device malfunction |
| Model numbers | 10764801, 10764802, 10764803, 10764804 |
Product
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
Reason for recall
Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.
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-2437-2015. 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.