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doi: 10.1016/j.dsx.2017.09.013 29 Yovera-AldanaMVelasquez-RimachiVHuerta-RosarioAMore-YupanquiMDOsores-FloresMEspinozaRet al

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The FDA noted that "CAPA CA 90 was initiated on April 9, 2024, for 731 Series Ventilators with MRI compatibility nonconformances, resulting in a Class I recall that was not initiated until April 30, 2024." The company's complaint analysis system failed to detect the pattern because complaints were coded as "User Errors," "No Fault Found," "No Product Returned," and "User Attempted Repairs." These ventilator failures "caused malfunctions and shutdowns that led to the stoppage of ventilatory support and the need for alternative means of ventilation." Even after closing the CAPA as effective in September 2024, Zoll received 6 complaints relating to the MRI compatibility issues from November 15, 2024, through January 16, 2025, after closure of the CAPA and no additional CAPAs have been initiated