ESAOTE S.P.A Recalls
9 recalls on record · July 13, 2016 to March 11, 2026 · Medical Devices
Recalls by year
16
18
20
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 11, 2026Medical DevicesFDA
ESAOTE S.P.A. recalls Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Hazard: 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.
October 7, 2020Medical DevicesFDA
ESAOTE S.P.A recalls AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated wi
Hazard: 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.
October 7, 2020Medical DevicesFDA
ESAOTE S.P.A recalls AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated wi
Hazard: 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.
October 31, 2018Medical DevicesFDA
ESAOTE S.P.A. recalls MyLab Seven, Model 6400
Hazard: 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.
October 31, 2018Medical DevicesFDA
ESAOTE S.P.A. recalls MyLab Gamma, Model 7410
Hazard: 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.
October 31, 2018Medical DevicesFDA
ESAOTE S.P.A. recalls MyLab Alpha, Model 7400
Hazard: 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.
March 28, 2018Medical DevicesFDA
ESAOTE S.P.A. recalls MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT34
Hazard: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
March 28, 2018Medical DevicesFDA
ESAOTE S.P.A. recalls MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Hazard: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
July 13, 2016Medical DevicesFDA
Esaote S.p.A. recalls Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Hazard: The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for weight-bearing examinations.