Home / Recalls / ESAOTE S.P.A. / Z-1490-2026

Z-1490-2026 Class II

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

Recall Details

Product Type
Devices
Report Date
March 11, 2026
Initiation Date
March 14, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

Reason for Recall

A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

Distribution Pattern

US: Nationwide distribution in the states of NC and TX.

Code Information

UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.

Other recalls by ESAOTE S.P.A.

  • 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-1138-2018 Class II — MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA5 (January 3, 2018)
  • Z-2124-2016 Class II — Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) (June 6, 2016)