ESAOTE S.P.A.: Medical Device Recall in 2018 - (Recall #: Z-1138-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 3, 2018

Date Posted: March 28, 2018

Recall Number: Z-1138-2018

Event ID: 79547

Reason for Recall:

The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

Status: Terminated

Product Quantity: 5

Code Information:

Software versions 12.10 - 13.60

Distribution Pattern:

US distribution in the states: AZ, FL, OK, PA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated