Purpose The Global Fund Quality Assurance and Compliance Team is issuing this QA Notice to share information on a recall related to certain Masimo Rad-G® Pulse Oximeter devices distributed worldwide by the manufacturer Masimo Corporation (USA). [...] Identification of the product(s) and manufacturer Masimo Corporation 52 Discovery Name of Manufacturer(s) Irvine CA 92618-3105 United States of America Commercial / Brand Name(s) Masimo Rad-G® Pulse Oximeter Formulation Not applicable - Masimo Rad-G® Pulse Oximeter with temperature (W/Sensor), REF: 9210, UDI: (01)00843997008013 - Masimo Rad-G® Pulse Oximeter (W/Patient Cable), Reference Number (RE. [...] FDA Medical Device Recalls Database ( es.cfm?start_search=1&event_id=94170) for a list of the serial numbers of the Masimo Rad-G® Pulse Oximeter devices subject to this Quality Notice. [...] Number of patients potentially Not identified impacted Action/Investigations to be taken Addressees are advised to identify and promptly remove impacted Masimo Rad-G® Pulse Oximeter devices from use and contact the Technical Services of Masimo Corporation ( ). [...] Please maintain awareness of this QA Notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
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