Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1138-2018 — 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

U.S. FDA — Device Enforcement · Italy · 2018-01-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1138-2018
Date of alert
2018-01-03
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
ESAOTE S.P.A.
Product category
device
Product type
Devices
Reported risk: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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