Sesto Fiorentino, N/A, Italy
ESAOTE S.P.A. recalls
4 recalls recorded since 2018, most recently on 14 March 2025. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 14 March 2025
- Reason
- 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
- US: Nationwide distribution in the states of NC and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1490-2026
- Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Terminated Class II Medical devices
- Recall started
- 8 September 2020
- Terminated
- 17 April 2023
- Reason
- The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3053-2020, Z-3052-2020
- AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with
- AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with
Terminated Class II Medical devices
- Recall started
- 11 June 2018
- Terminated
- 12 May 2020
- Reason
- The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
- Distribution
- Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0205-2019, Z-0204-2019, Z-0206-2019
- MyLab Gamma, Model 7410
- MyLab Alpha, Model 7400
- MyLab Seven, Model 6400
Terminated Class II Medical devices
- Recall started
- 3 January 2018
- Terminated
- 30 May 2019
- Reason
- The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
- Distribution
- US distribution in the states: AZ, FL, OK, PA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1138-2018, Z-1137-2018
- 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
- MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.