13 results
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38ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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)
FDA Recall
Terminated
·ESAOTE S.P.A Via Enrico Melen·Product code IYN·September 8, 2020
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)
FDA Recall
Terminated
·ESAOTE S.P.A Via Enrico Melen·Product code IYN·September 8, 2020
Esaote brand Formul@ ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand ArchiWin Colour ECG System; part 9704325000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Archimed 4220 ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Formula for Archimed ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
FDA Recall
Terminated
·Esaote S.p.A. Via Di Caciolle, 15 Firenze Italy·Product code LNH·June 6, 2016
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Recall
Completed
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code ITX·March 14, 2025
MyLab Gamma, Model 7410
FDA Recall
Terminated
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·June 11, 2018
MyLab Alpha, Model 7400
FDA Recall
Terminated
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·June 11, 2018
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
FDA Recall
Terminated
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·January 3, 2018
MyLab Seven, Model 6400
FDA Recall
Terminated
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·June 11, 2018
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
FDA Recall
Terminated
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·January 3, 2018