ESAOTE MyLab Alpha Ultrasound System Recalled for Probe Overheating Risk
ESAOTE S.P.A. is recalling 10 MyLab Alpha Model 7400 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (overheating causing discomfort/pain) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
ESAOTE S.P.A. is recalling 10 units of the MyLab Alpha, Model 7400 ultrasound system. The recall is due to probe power monitoring settings that are not appropriate under specific operating conditions when connected to certain devices. This issue may result in the overheating of the probe head surface within approximately one minute of continuous operation.
The potential hazard includes patient discomfort, reddening of the epidermis, and/or mild pain. To date, no patient injuries have been reported regarding this issue.
The affected units were distributed worldwide, including in the United States (AK, AZ, CA, IN, MO, NM, PA, SC, and TX) and numerous international countries. Consumers and healthcare providers should contact ESAOTE S.P.A. for further instructions on how to address this issue.
The recalled product
- Product
- MyLab Alpha, Model 7400
- Manufacturer
- ESAOTE S.P.A.
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- n/a
Distribution
Part of a larger recall action
This product is one of 3 recalled by ESAOTE S.P.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · ESAOTE S.P.A.
See all →- HighEsaote endocavity ultrasound probe recalled because liquid may leak in
FDA (Devices) · 2026-03-11
- SevereESAOTE Portable Ultrasound AC/DC Power Supply Recall for Overheating Risk
FDA (Devices) · 2020-10-07
- SevereESAOTE AC/DC Power Supply Recall for Portable Ultrasound Systems
FDA (Devices) · 2020-10-07
- HighESAOTE MyLab Gamma Ultrasound System Recalled for Probe Overheating Risk
FDA (Devices) · 2018-10-31
- HighESAOTE MyLab Seven Ultrasound System Recalled for Probe Overheating Risk
FDA (Devices) · 2018-10-31
Same hazard · overheating
See all →- ModerateGentherm Medical Recalls Blanketrol II Thermal Regulating Systems
FDA (Devices) · 2026-08-26
- HighGentherm Medical Recalls Blanketrol III Thermal Regulating Systems
FDA (Devices) · 2026-08-26
- HighGentherm Medical Recalls Innercool Coolblue Console Due to Overheating Risk
FDA (Devices) · 2026-08-26
- Severe
- SevereTherabody Theragun G4 PRO Charger Recalled for Fire Risk
FDA (Devices) · 2026-08-12