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Devices
Device Recall MyLab Ultrasound System
Model / Serial
Software versions 12.10 - 13.60
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US distribution in the states: AZ, FL, OK, PA, and TX.
Product Description
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
Manufacturer
ESAOTE S.P.A.
1 Event
Recall of Device Recall MyLab Ultrasound System
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Manufacturer
ESAOTE S.P.A.
Manufacturer Address
ESAOTE S.P.A., Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino Italy
Manufacturer Parent Company (2017)
Wansheng Medical Investments (Hong Kong) Limited
Source
USFDA
One device with a similar name
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Device Recall MyLab Ultrasound System
Model / Serial
Software versions 4.0 - 13.60
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US distribution in the states: AZ, FL, OK, PA, and TX.
Product Description
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Manufacturer
ESAOTE S.P.A.
Language
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