Class II — Esaote S.p.A.
| Recalling firm | ESAOTE S.P.A. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) |
| Quantity | 11 USA; 29 OUS |
| Distribution | Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD. |
| Initiated | 2016-06-06 |
| Classified | 2016-07-05 |
| Terminated | 2017-05-30 |
| Recall number | Z-2124-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Esaote S.p.A. (Z-2124-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74391/
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