Z-0206-2019Class II

MyLab Seven, Model 6400

Name: Z-0206-2019 MyLab Seven, Model 6400
Creator: Esaote S.p.a.
Published: 2018-06-11
License: https://open.fda.gov/license/

Esaote S.p.A. / initiated 2018-06-11 / Terminated / root cause: software

FDA source

ESAOTE S.P.A. began a recall of MyLab Seven, Model 6400 on 2018-06-11. FDA classified it as Class II and gives the reason as "The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe...". 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-0206-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-11
Posted: 2018-10-23
Terminated: 2020-05-12
Recalling firm: Esaote S.p.A.
Product: MyLab Seven, Model 6400
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
Root cause tag: software
FDA root cause: Software design
Action: On June 11, 2018, the firm notified IH 6-18 probe customers of the product issue through a Field Safety Notice. The letter described the issue and stated that Esaote would provide and install a corrective software update for each affected unit at no cost to the customer. Until the customer receives the corrective software update, customer is requested to refrain from use of the probe IH 618 in BTEI mode or any combined mode including BTEI in Pediatric, Neonatal and Intraoperative clinical applications. For all the other applications, you are requested to monitor the possible temperature rise at the surface of the probe head and immediately stop scanning if the patient notices any discomfort. As a general safety rule, it is recommended to use the probe in default settings, to keep the examination time as short as is necessary to produce a useful diagnostic result and not to hold the probe in a fixed position for any longer than is strictly necessary. Customers are requested to distribute this Field Safety Notice to all appropriate personnel in their organization and forward to all users of the systems, including others to whom they may have transferred the systems, in which case the customer is requested to provide information to Esaote regarding the new owner.
Quantity in commerce: 10
Distribution: Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy Japan Kuwait Mexico Netherlands Norway Paraguay Poland Portugal Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Switzerland Taiwan Thailand Tunisia Turkey United Kingdom Utd.Arab Emir.
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0204-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0205-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0206-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

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)