FDA Device recall Z-1138-2018
MyLab Ultrasound System
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of MyLab Ultrasound System by Esaote S P A, citing the ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1138-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-03 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Esaote S P A |
| Distribution | AZ, FL, OK, PA, TX |
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
Reason
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Identifiers
| code_info | Software versions 12.10 - 13.60 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1138-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.