Recall Z-3053-2020— ESAOTE S.P.A

Name: FDA recall Z-3053-2020
Creator: U.S. Food and Drug Administration
Published: 2020-09-08

Class II · Terminated

Class II FDA medical device recall by ESAOTE S.P.A, initiated 2020-09-08, terminated 2023-04-17. It names one FDA 510(k) clearance: K161359. Product: AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, 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). 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..

Recalling firm: ESAOTE S.P.A
Classification: Class II
Status: Terminated
Initiated: 2020-09-08
Terminated: 2023-04-17
Firm location: Genova, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K161359 — 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.·cleared 2016-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, 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)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.