ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk
ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat in certain settings.
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 is classified as FDA Class II and involves a risk of thermal injury (burns) from overheating, which fits the criteria for high-risk products where injury has not yet been reported.
Plain-English summary
ESAOTE S.P.A. is recalling MyLab Ultrasound Systems, including models 6100, 6150, 6200, and 6250, equipped with the PA023E Probe 7.5/10. The recall involves software versions 4.0 through 13.60. The agency classifies this as a Class II recall.
The recall is being conducted because the ultrasound system used in certain settings may result in overheating of the ultrasound probe head. This defect poses a risk of thermal injury to patients or operators.
The affected units were distributed in the United States in the states of Arizona, Florida, Oklahoma, Pennsylvania, and Texas. Users of these devices should contact ESAOTE S.P.A. for further instructions on how to address the overheating issue.
The recalled product
- Product
- MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
- Manufacturer
- ESAOTE S.P.A.
- Hazard
- Affected units
- 1
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)
- Software versions 4.0 - 13.60
Distribution
Part of a larger recall action
This product is one of 2 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.
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