Facility

ESAOTE S.P.A.

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012981490
Establishment type	Manufacture Medical Device
Location	Via degli Olmi 11 Sesto Fiorentino Firenze, IT 50019
Registration status	Active · expires 2026
Parent company	ESAOTE S.P.A. (owner-operator 8021005)
Brand names	MyLabX6; 6400 Model; MyLabX7

Activity by year

Recalls (5)

Devices registered here (3)

Transducer, Ultrasonic, Diagnostic
Product code ITX (opens in a new tab) · Class II · Radiology · 21 CFR 892.1570
System, Imaging, Pulsed Doppler, Ultrasonic
Product code IYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.1550
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560

Recalls & enforcement

Class IICompleted2025-03-14
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.
Class IITerminated2020-09-08
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 o…
Class IITerminated2018-06-11
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 …
Class IITerminated2018-01-03
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Class IITerminated2016-06-06
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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ESAOTE S.P.A. (FEI 3012981490) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012981490-esaote-s-p-a/

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