Recall Z-0204-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ESAOTE S.P.A.
MyLab Alpha, Model 7400
| Date | Jun 11, 2018 |
| 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. |
| Root cause | Software design |
| Action | On June 11, 2018, the firm notified IH 6-18 probe customers of the product issue through a Field Safety Notice. The letter described the issue and stated that Esaote would provide and install a corrective software update for each affected unit at no cost to the customer. Until the customer receives the corrective software update, customer is requested to refrain from use of the probe IH 618 in BTEI mode or any combined mode including BTEI in Pediatric, Neonatal and Intraoperative clinical applications. For all the other applications, you are requested to monitor the possible temperature rise |
| 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 |
| FDA record | Open on fda.gov |