Esaote PA230E Ultrasound Transducer Recalled for Excessive Surface Temperature

Plain-English summary

Biosound Esaote, Inc. is recalling 1,301 units of the Esaote PA230E Transducer, a component for portable and cart-based ultrasound systems used for general and cardiovascular imaging. The recall is due to a potential safety hazard where the transducer surface temperature could exceed the maximum allowable limit. This condition may occur when the device is used with a user-defined setting that sets the output power to 100% (Max) in 2D-TEI mode while focusing at maximum depth.

The affected products were shipped nationwide to 48 states, the District of Columbia, Puerto Rico, and Canada. The recall includes specific part numbers 9600165000 and 97154411675, along with a list of specific serial numbers. Users of these ultrasound systems should check their equipment against the provided serial numbers to determine if they are affected.

Consumers and healthcare facilities should stop using the affected transducers if they match the identified serial numbers and contact the recalling firm for further instructions or a replacement.

The recalled product

Product

Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging

Manufacturer

Biosound Esaote, Inc.

Category

Medical Device — Ultrasound Transducer

Hazard

• burn-injury

Affected units

1,301

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls