Device product
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Z-1137-2018
Product summary
- Firm
- ESAOTE S.P.A.
- Event
- Event 79547
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1137-2018
Official wording
Reason: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Code information: Software versions 4.0 - 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.