Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Applied Medical Resources Corporation, has issued a medical device safety alert concerning its Zimmer P Voyant EA020 Electrosurgical Generator (Model number: EA020) [HKMD Number: 220435].
According to the manufacturer, this recall is due to the identification of an electrical board component from a non-approved manufacturer, thereby making it non-conforming to our UL approved Safety Certification Report list of critical components. This non-conformance presents no risk to the patient or user safety and does not impact the use of compatible Voyant devices.
The generators manufactured as part of the affected lots passed all functional and production testing to comply with IEC 60601-1 and 60601-2-2 standards for electrical systems. In the event the non-conforming component fails, the generator would trigger an "Unrecognized Device" error on the screen, rendering the generator inoperable.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Apr 2024