Torque wrench used on the bolts for the Symbia T2 model 10275008 — Class II medical device recall Z-0047-2018
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2017-11-01, distributed in CA, FL, GA, LA, NY, PA, TN. The torque wrench used to tighten system bolts during installation was found to be out of tolerance
| Recall number | Z-0047-2018 |
|---|---|
| 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 | 2017-09-18 |
| Classified | 2017-10-25 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2017-12-11 |
| Distributed | CA, FL, GA, LA, NY, PA, TN |
| Quantity | 16 devices |
| Serial numbers | 1049, 1054, 1071, 1075, 1104, 1109, 1111, 1128, 1131, 1134, 1158, 2001, 2100, 2112, 2116, 2140 |
| Model numbers | 10275008, 10764801, 10764804, 10910500, 10910501 |
Product
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
Reason for recall
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
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-0047-2018. 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.