The U.S. Food and Drug Administration (FDA) has issued a warning letter to Zoll Medical over quality system violations related to its MRI-compatible ventilators.
Following an inspection at the company's Chelmsford, MA, facility, the FDA found that Zoll failed to adequately validate labeling for its 731 Series MRI-compatible ventilators, which are intended for use with 1.5-tesla and 3-tesla MRI scanners. MRI compatibility testing was performed using only a 3-tesla scanner, with no documented rationale for the omission of 1.5-tesla testing, according to the letter. The agency also noted that Zoll received a complaint in July 2024 in which a customer confirmed the ventilator was used near 1.5-tesla MRI equipment and affected imaging quality.
Zoll has 15 business days to respond to the letter, the FDA said.
