MyLab Ultrasound System — Class II medical device recall Z-1137-2018
Terminated recall by ESAOTE S.P.A., reported 2018-03-28, distributed in AZ, FL, OK, PA, TX. The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
| Recall number | Z-1137-2018 |
|---|---|
| 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 | 2018-01-03 |
| Classified | 2018-03-20 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-05-30 |
| Distributed | AZ, FL, OK, PA, TX |
| Quantity | 1 |
| Reason classes | device malfunction |
| Model numbers | 6100, 6150, 6200, 6250 |
Product
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Reason for recall
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
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-1137-2018. 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.