MyLab Gamma, Model 7410
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEsaote Endocavity ultrasonic probe, Model E 3-12, REF 1200000382025-03-14
- FDAAC/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 ...2020-09-08
- FDAAC/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 ...2020-09-08
- FDAMyLab Alpha, Model 74002018-06-11
- FDAMyLab Seven, Model 64002018-06-11
- FDAMyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/102018-01-03
- FDAMyLab 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, TRT332018-01-03
- FDAMagnetic Resonance System G-scan Brio (Part Number /Model No.101002000)2016-06-06
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