FDA | 合法醫療器材資訊網
2021年4月12日—Thedevicesarebeingrecalledduetoanunexpectedandrapiddecreaseinbatterylifecausedbyashortcircuit.Thisdefectmaycasesome ...
The devices may have battery issues that can lead to full battery depletion within a single day.The US Food and Drug Administration is warning physicians about a recall initiated in February for several implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured by Medtronic: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia. Today, the FDA categorized this action as a Class I recall, its most serious type, meaning that use could cause serious injuries or death.
The devices are being recalled due to an unexpected and rapid decrease in battery life caused by a short circuit. This defect may case some devices to prematurely produce a “Recommended Replacement Time” (RRT) low-battery warning as well proceed to full battery depletion within as little as 1 day.
“If the user does not respond to the first warning, the devi...
Medtronic Recalls Evera, Viva, Brava, Claria | 合法醫療器材資訊網
2021 Medical Device Recalls | 合法醫療器材資訊網
Medtronic Recalls its ICDs and CRT | 合法醫療器材資訊網
FDA | 合法醫療器材資訊網
Medtronic Extends Voluntary Recall to Include 752 ICDs and ... | 合法醫療器材資訊網
Urgent Medical Device Correction | 合法醫療器材資訊網
Medtronic Recall of Almost 240 | 合法醫療器材資訊網
FDA classifies Medtronic ICD | 合法醫療器材資訊網
FDA details Class I recall of nearly 240 | 合法醫療器材資訊網
Medtronic Cardiac Defibrillators Recalled Due To Plant Problem | 合法醫療器材資訊網
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