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 ultrasound system used in certain settings may result in overheating of the ultrasound probe head. |
| Product | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 |
| Quantity | 1 |
| Distribution | US distribution in the states: AZ, FL, OK, PA, and TX. |
| Initiated | 2018-01-03 |
| Classified | 2018-03-20 |
| Terminated | 2019-05-30 |
| Recall number | Z-1137-2018 |
| 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-1137-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79547/
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