The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0206-2019·Announced 2018-10-31

ESAOTE MyLab Seven Ultrasound System Recalled for Probe Overheating Risk

ESAOTE is recalling 10 MyLab Seven ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 probe) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.

Plain-English summary

ESAOTE S.P.A. is recalling 10 units of the MyLab Seven, Model 6400 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 in approximately one minute of continuous operation.

The affected units were distributed worldwide, including in the United States (specifically in AK, AZ, CA, IN, MO, NM, PA, SC, and TX) and in numerous international countries. To date, no patient injury has been reported regarding this issue, though patients may experience discomfort, reddening of the epidermis, and/or mild pain if the probe overheats.

Consumers and healthcare facilities should contact ESAOTE S.P.A. for further instructions on how to address this issue with the affected equipment.

The recalled product

Product
MyLab Seven, Model 6400
Manufacturer
ESAOTE S.P.A.
Category
Medical Device — Ultrasound System
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

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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 →

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