Z-1138-2018Class II

MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618...

Name: Z-1138-2018 MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618...
Creator: Esaote S.p.a.
Published: 2018-01-03
License: https://open.fda.gov/license/

Esaote S.p.A. / initiated 2018-01-03 / Terminated / root cause: software

FDA source

ESAOTE S.P.A. began a recall of 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... on 2018-01-03. FDA classified it as Class II and gives the reason as "The ultrasound system used in certain settings may result in overheating of the ultrasound probe head". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1138-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Posted: 2018-03-20
Terminated: 2019-05-30
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Root cause tag: software
FDA 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 in commerce: 5
Distribution: US distribution in the states: AZ, FL, OK, PA, and TX.
Product codes and lots: Software versions 12.10 - 13.60

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1138-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1137-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20
Z-1138-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)