The Siemens Symbia S series is intended to aid in detecting — Class II medical device recall Z-1086-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-02-18, distributed nationwide. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
| Recall number | Z-1086-2015 |
|---|---|
| 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 | 2012-10-23 |
| Classified | 2015-02-10 |
| Reported by FDA | 2015-02-18 |
| 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, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IT, JP, KW, LT, LV, MA, MX, NL, NO, NZ, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SK, TH, TN, TR, VE, ZA |
| Quantity | 719 systems |
| Serial numbers | 1001, 1002, 1003, 1005, 1006, 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1021, 1022, 1023, 1024, 1025, 1027 and 475 more |
Product
The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Reason for recall
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-1086-2015. 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.