Recall Z-1138-2018 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ESAOTE S.P.A.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
| Date | Jan 3, 2018 |
| Status | Terminated |
| Reason | The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. |
| Root cause | Software design |
| Action | The January 3, 2018, notification letter requests the consignee complete and return a recall response form. The letter states that Esaote customer service will contact the consignee about the software update. In the meantime, it is recommended that the consignee does not use the PA023E probe in Pulsed Wave (PW) Doppler mode and that they refrain from using the system in Elaxto mode where the patient is unconscious or sedated. The consignee is asked to check the temperature of the probe before use. |
| Quantity | 5 |
| Distribution | US distribution in the states: AZ, FL, OK, PA, and TX. |
| FDA record | Open on fda.gov |