Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image… — Class II medical device recall Z-0062-2017
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2016-10-19, distributed nationwide. The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically
| Recall number | Z-0062-2017 |
|---|---|
| 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 | 2013-08-16 |
| Classified | 2016-10-07 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, HK, HR, HU, ID, IE, IL, IN, IR, IT, JP, KR, KW, LT, LV, MA, MX, NL, NO, NZ, PE, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, VE, VN, ZA |
| Quantity | 1,109 units |
| Serial numbers | 1000, 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1021, 1022, 1023, 1024 and 327 more |
Product
Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.
Reason for recall
The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
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-0062-2017. 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.