Recall Z-3053-2020 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ESAOTE S.P.A
AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (1
| Date | Sep 8, 2020 |
| Status | Terminated |
| Reason | The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction letters were sent to customers on 9/8/20. ACTION TO BE TAKEN BY THE USERS Using the ultrasound system as specified in the system user manual does not pose any safety risk. As instructed in the system user manual, never disconnect the power cord from the AC/DC Adapter when the power cord is plugged into the wall outlet. The customer and any system user is requested to: " Verify the mains cable has not been changed since purchasing the system. If the cable is not the original supplied by Esaote, contact your local Esaote service representative for assistance. " |
| Quantity | 989 total adapters in the US |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System Esaote, S.p.A., Jul 19, 2016 |