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
This recall has been terminated (originally issued January 3, 2018).
- Recall Initiated
- January 3, 2018
- Terminated
- May 30, 2019
- Recall Number
- Z-1138-2018
- Quantity
- 5
- Official Source
- View on FDA website ↗
Reason for Recall
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Distribution
US distribution in the states: AZ, FL, OK, PA, and TX.
Lot / Code Info
Software versions 12.10 - 13.60
Root Cause
Software design
Action Taken
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.