Z-1138-2018 Class II Terminated
FDA device recall Z-1138-2018 was initiated by ESAOTE S.P.A. on Jan 3, 2018 and is designated Class II. Reason for recall: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. The recall status is terminated (terminated May 30, 2019). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 28, 2018
- Initiation Date
- Jan 3, 2018
- Termination Date
- May 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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.
Distribution Pattern
US distribution in the states: AZ, FL, OK, PA, and TX.
Code Information
Software versions 12.10 - 13.60
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1138-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026