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 probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue. |
| Product | MyLab Alpha, Model 7400 |
| Quantity | 10 |
| Distribution | Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy Japan Kuwait Mexico Netherlands Norway Paraguay Poland Portugal Russian Fed. Saudi Arabia… |
| Initiated | 2018-06-11 |
| Classified | 2018-10-23 |
| Terminated | 2020-05-12 |
| Recall number | Z-0204-2019 |
| 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-0204-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81285/
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