The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0205-2019·Announced 2018-10-31

ESAOTE MyLab Gamma Ultrasound System Recalled for Probe Overheating Risk

ESAOTE S.P.A. is recalling 10 MyLab Gamma, Model 7410 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 is classified as FDA Class II and involves a risk of harm (overheating causing discomfort or mild pain) where no injury has yet been reported, fitting the criteria for a High severity score.

Plain-English summary

ESAOTE S.P.A. is recalling 10 units of the MyLab Gamma, Model 7410 ultrasound system. The recall was initiated because the probe power monitoring settings were found to be inappropriate under specific operating conditions when connected to certain devices. This issue may result in the overheating of the probe head, with the surface potentially overheating in around one minute of continuous operations.

The affected units were distributed worldwide, including in the United States (specifically in AK, AZ, CA, IN, MO, NM, PA, SC, and TX) and numerous international countries. The source text notes that to date, no patient injury has been reported with regards to this issue. However, the text states that a patient 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. The recall is classified as Class II by the FDA.

The recalled product

Product
MyLab Gamma, Model 7410
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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