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
Reported: March 28, 2018 Initiated: January 3, 2018 #Z-1138-2018
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
Reason for Recall
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Details
- Recalling Firm
- ESAOTE S.P.A.
- Units Affected
- 5
- Distribution
- US distribution in the states: AZ, FL, OK, PA, and TX.
- Location
- Sesto Fiorentino, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ESAOTE S.P.A.. Units affected: 5.
Why was this product recalled? ▼
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 28, 2018. Severity: Moderate. Recall number: Z-1138-2018.
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