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Z-0205-2019 Class II Terminated

Recalled by ESAOTE S.P.A. — Sesto Fiorentino, N/A

FDA device recall Z-0205-2019 was initiated by ESAOTE S.P.A. on June 11, 2018 and is designated Class II. 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 p… The recall status is terminated (terminated May 12, 2020). Affected quantity: 10.

Recall Details

Product Type: Devices
Report Date: October 31, 2018
Initiation Date: June 11, 2018
Termination Date: May 12, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10

Product Description

MyLab Gamma, Model 7410

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.

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.

Code Information

n/a

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