MyLab Seven recalled over fire hazard

Recall date

June 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ESAOTE S.P.A. recalls MyLab Seven, Model 6400

Recall number

Z-0206-2019

FDA classification

Class II

Brand / firm

ESAOTE S.P.A.

Sold / distributed

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 Mexic…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MyLab Seven, Model 6400