Recall Z-1138-2018— ESAOTE S.P.A.
Class II · Terminated
Class II FDA medical device recall by ESAOTE S.P.A., initiated 2018-01-03, terminated 2019-05-30. It names 2 FDA 510(k) clearances: K163082, K081386. Product: 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. Reason: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head..
- Recalling firm
- ESAOTE S.P.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-03
- Terminated
- 2019-05-30
- Firm location
- Sesto Fiorentino, N/A, Italy
510(k) clearances named in this recall
2 on FDA's record- K163082 — 6200 Ultrasound System and 6250 Ultrasound System
- K081386 — MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Data sourced from openFDA. This site is unofficial and independent of the FDA.