FDA-Device2018-10-31Class II
MyLab Gamma, Model 7410
ESAOTE S.P.A.
Hazard
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.
Sold states
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.
Affected count
10
Manufactured in
Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino, N/A, Italy
Products
MyLab Gamma, Model 7410
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2019Don't want to check this manually?
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