ESAOTE S.P.A.: Medical Device Recall in 2018 - (Recall #: Z-0204-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

MyLab Alpha, Model 7400

Product Classification:

Class II

Date Initiated: June 11, 2018

Date Posted: October 31, 2018

Recall Number: Z-0204-2019

Event ID: 81285

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.

Status: Terminated

Product Quantity: 10

Code Information:

n/a

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated