FDA (Devices) recall action 81285
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
ESAOTE S.P.A. is recalling 10 MyLab Gamma, Model 7410 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.
ESAOTE is recalling 10 MyLab Seven ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.
ESAOTE S.P.A. is recalling 10 MyLab Alpha Model 7400 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.