MyLab Ultrasound System recall
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435…
Why was MyLab Ultrasound System recalled?
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions 12.10 - 13.60
- Product
- MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435…
- Recalling firm
- ESAOTE S.P.A.
- Quantity
- 5
- Distribution
- US distribution in the states: AZ, FL, OK, PA, and TX.
- Recall date
- March 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)