FDA Issues Warning Letter to Philips Over Quality System Deficiencies

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Philips citing quality issues at three facilities producing ultrasound equipment and software for cardiac imaging and telehealth. The letter, dated September 9, 2025, followed FDA inspections of facilities in Washington, Pennsylvania, and the Netherlands earlier in the year.

The FDA identified multiple deficiencies in complaint handling, corrective actions, and reporting practices. Philips failed to document proper evaluation of complaints, including incidents involving broken ultrasound probes and malfunctioning transesophageal transducers, some of which were incorrectly classified as non-complaints. Additionally, Philips refurbished expired transducers beyond their three-year service life and neglected to submit timely reports of device corrections or removals—such as a 2022 voltage issue—to the FDA within the required 10 days.

Philips stated it is implementing a multi-year program to strengthen its quality systems, addressing documentation and procedural gaps. Despite the warning, the company expects no material impact on operations, and affected products remain on the market.

03-11-2025