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Terminated

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 Z-1138-2018 · Posted None

Recalling FirmESAOTE S.P.A.
Recall StatusTerminated
Product CodeIYN
Date Initiated2018-01-03
Date Terminated2019-05-30
Product Quantity5

Reason for Recall

The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

Firm Action

The January 3, 2018, notification letter requests the consignee complete and return a recall response form. The letter states that Esaote customer service will contact the consignee about the software update. In the meantime, it is recommended that the consignee does not use the PA023E probe in Pulsed Wave (PW) Doppler mode and that they refrain from using the system in Elaxto mode where the patient is unconscious or sedated. The consignee is asked to check the temperature of the probe before use.

Root Cause

Software design

Distribution Pattern

US distribution in the states: AZ, FL, OK, PA, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017-03-16K081386MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)Esaote, S.p.A. · 2008-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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