MyLab Gamma — Class II medical device recall Z-0205-2019
Terminated recall by ESAOTE S.P.A., reported 2018-10-31, distributed nationwide. The probe power monitoring settings have been found to be not appropriate under specific operating conditions
| Recall number | Z-0205-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ESAOTE S.P.A., Sesto Fiorentino, N/A, Italy |
| Recall initiated | 2018-06-11 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BR, CH, CN, CR, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, IN, IR, IS, IT, JP, KR, KW, MX, NL, NO, PL, PT, PY, SA, SG, SI, TH, TN, TR, TW, ZA |
| Quantity | 10 |
| Reason classes | device malfunction |
| Model numbers | 7410 |
Product
MyLab Gamma, Model 7410
Reason for recall
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.
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-0205-2019. 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.