FDA Medical Device Recalls (openFDA)
ESAOTE S.P.A.: 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
- Recall number
- Z-1138-2018
- Recalling firm
- ESAOTE S.P.A.
- 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
- Status
- Terminated
- Initiated
- 2018-01-03
- Posted
- not on file
- Terminated
- 2019-05-30
- Reason
- The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
- Root cause
- Software design
- 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.
- Quantity
- 5
- Distribution
- US distribution in the states: AZ, FL, OK, PA, and TX.
- Lot, serial or model codes
- Software versions 12.10 - 13.60
- 510(k) numbers
- ["K081386","K163082"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3012981490
- Firm city
- Sesto Fiorentino
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28