Home / Recalls / ESAOTE S.P.A. / Z-1138-2018

Z-1138-2018 Class II Terminated

Recalled by ESAOTE S.P.A. — Sesto Fiorentino, N/A

Recall Details

Product Type
Devices
Report Date
March 28, 2018
Initiation Date
January 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

Other recalls by ESAOTE S.P.A.

  • Z-1490-2026 Class II — Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 (March 14, 2025)
  • Z-3052-2020 Class II — AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180 (September 8, 2020)
  • Z-3053-2020 Class II — AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180 (September 8, 2020)
  • Z-0205-2019 Class II — MyLab Gamma, Model 7410 (June 11, 2018)
  • Z-0206-2019 Class II — MyLab Seven, Model 6400 (June 11, 2018)
  • Z-0204-2019 Class II — MyLab Alpha, Model 7400 (June 11, 2018)
  • Z-1137-2018 Class II — MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 (January 3, 2018)
  • Z-2124-2016 Class II — Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) (June 6, 2016)