ESAOTE S.P.A: AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

Recall number

Z-3052-2020

Recalling firm

ESAOTE S.P.A

Product

AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

Status

Terminated

Initiated

2020-09-08

Posted

not on file

Terminated

2023-04-17

Reason

The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.

Root cause

Device Design

Action

Urgent Medical Device Correction letters were sent to customers on 9/8/20. ACTION TO BE TAKEN BY THE USERS Using the ultrasound system as specified in the system user manual does not pose any safety risk. As instructed in the system user manual, never disconnect the power cord from the AC/DC Adapter when the power cord is plugged into the wall outlet. The customer and any system user is requested to: " Verify the mains cable has not been changed since purchasing the system. If the cable is not the original supplied by Esaote, contact your local Esaote service representative for assistance. " In case you see unexpected alert messages on the screen reporting that the system is out of power and not plugged in when in fact the mains cable and AC/DC power adapter are connected, you are requested to refrain the use of the system and contact your local Esaote service representative for assistance " If you observe smoke coming from the system or the AC/DC Power adapter, immediately unplug the mains power cord from the wall outlet, removing power to the system. If the ultrasound system continues to operate via batteries, power down the system. You are requested to refrain from using the ultrasound system and to contact your local Esaote service representative for assistance. " Never disconnect the power cable from the AC/DC adapter when the power cord is plugged into the wall outlet. As recommended in the User Manual of the system, in Getting Started chapter 3 and chapter 5 to insulate the system from the mains always disconnect the cable from the power outlet. " With the system off and completely unplugged from the wall outlet, you can remove the mains power cord from the AC/DC adapter to inspect the cable and outlet on the AC/DC adapter for any damage, such as melting of the corner of the mains power cord where it plugs into the AC/DC adapter. If you see damage or suspect the mains power cord or AC/DC adapter are possibly damaged, you are requested to r

Quantity

989 total adapters in the US

Distribution

US Nationwide

Lot, serial or model codes

Serial Numbers: Below K17510001

510(k) numbers

["K161359"]

PMA numbers

not on file

Product code

IYN

Firm FEI

3014563045

Firm city

Genova

Firm state

not on file

Firm country

Italy

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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