The FDA issued a warning letter to medical devicemaker ZOLL Medical Corp. citing quality system and medical device reporting violations involving several products, including defibrillators, ventilators, electrodes and sensors.
The warning letter, dated April 30, follows an FDA inspection conducted between Feb. 27 and April 15, 2025. FDA investigators found that ZOLL failed to adequately establish and maintain procedures for corrective and preventive actions, design validation, risk analysis and supplier controls.
Among the findings, the agency said ZOLL did not appropriately investigate or escalate quality issues involving its MRI-compatible ventilators, X Series defibrillators and Accuvent sensors. FDA cited a Class I recall involving the company’s 731 Series ventilators and said the firm received six additional complaints related to MRI compatibility issues after a corrective action was closed.
The agency also said ZOLL failed to submit a required medical device report within the 30-day timeframe after becoming aware of a ventilator malfunction involving MRI use. The FDA received the report March 10, 2025, after the company became aware of the event June 20, 2024.
The agency warned that failure to adequately address the findings could result in enforcement actions, including seizure, injunctions and civil money penalties.
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