Device product
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
Z-1138-2018
Product summary
- Firm
- ESAOTE S.P.A.
- Event
- Event 79547
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-1138-2018
Official wording
Reason: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Code information: Software versions 12.10 - 13.60
Distribution pattern: US distribution in the states: AZ, FL, OK, PA, and TX.
Derived failure modes
-
Unknown
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.