The FDA has issued a warning letter to ZOLL Medical Corp. following an inspection of the company’s Chelmsford, Massachusetts, facility that identified multiple quality system and medical device reporting violations involving several cardiac and respiratory care products.

The warning letter stems from an inspection conducted between Feb. 27 and April 15, 2025. FDA investigators reviewed manufacturing and quality processes for products including the X Series/Advanced automated external defibrillators, MR-compatible 731 Series ventilators, OneStep electrodes and AccuVent sensors.

According to the agency, ZOLL failed to adequately implement corrective and preventive action (CAPA) procedures, including the escalation and investigation of quality issues. FDA cited examples involving OneStep pediatric electrodes, MR-compatible ventilators and complaints related to end-tidal CO2 monitoring and AccuVent sensor performance.
The agency also raised concerns about design validation activities for the company’s MR-compatible ventilators. FDA said testing supporting MR compatibility claims did not adequately address use with 1.5 Tesla MR systems and questioned whether all ventilator configurations were properly evaluated. The letter references a complaint involving image quality issues during use near a 1.5T MR scanner.

Additional observations involved risk management practices, supplier controls and complaint trending processes. FDA said some supplier classifications did not reflect the potential impact of supplied components and services on device safety and effectiveness.

The warning letter also cites a medical device reporting violation. FDA said ZOLL did not submit a report within the required 30-day period after becoming aware of a ventilator malfunction associated with operation near an MR environment. The agency stated the ventilator is a life-supporting device and that recurrence of the malfunction could contribute to serious injury or death.

Separately, FDA said its understanding of ZOLL’s RescueNet Live software suggests the product may function as a medical device because it analyzes monitoring data and generates secondary alarms. The agency indicated that, if confirmed, the software could require additional regulatory clearance or approval.

FDA requested a written response within 15 business days outlining corrective actions and implementation timelines. Failure to adequately address the issues could result in enforcement actions, including seizure, injunction or civil monetary penalties.

Back to HCB News

Emergency Medicine Homepage