The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2167-2014·Announced 2014-08-20

Esaote PA230E Ultrasound Transducer Recalled for Excessive Surface Temperature

Biosound Esaote, Inc. is recalling 1,301 PA230E ultrasound transducers because they may exceed maximum allowable surface temperature limits under specific settings.

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 the hazard involves a risk of harm (excessive temperature) where no specific injuries or illnesses have been reported in the source text.

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
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.

Lot numbers (20)

  • Part #: 9600165000 PROBE
  • PA230E Serial #'s: 07011
  • 10005
  • 10007
  • 10010
  • 10011
  • 10012
  • 10013
  • 10015
  • 10017
  • 10021
  • 10042
  • 10068
  • 10070
  • 10079
  • 10085
  • 10086
  • 10087
  • 10088
  • 10089

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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