FDA Device recall Z-0206-2019
MyLab Seven, Model 6400
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of MyLab Seven, Model 6400 by Esaote S P A, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0206-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-11 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Esaote S P A |
| Distribution | US |
Product
MyLab Seven, Model 6400
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.
Identifiers
| code_info | n/a |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2019%22
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