Magnetic Resonance System G-scan Brio — Class II medical device recall Z-2124-2016
Terminated recall by Esaote S.p.A., reported 2016-07-13, distributed in FL, MN, NV, OH, TX. The device is being recalled because dynamic loading forces from larger patients can fracture the extremity po
| Recall number | Z-2124-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Esaote S.p.A., Firenze, N/A, Italy |
| Recall initiated | 2016-06-06 |
| Classified | 2016-07-05 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-05-30 |
| Distributed | FL, MN, NV, OH, TX |
| Countries outside the US | CA |
| Reason classes | device malfunction |
| Serial numbers | 101002000 |
| Model numbers | 101002000 |
Product
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Reason for recall
The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for weight-bearing examinations.
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-2124-2016. 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.