The Food and Drug Administration sent a warning letter to Philips related to quality issues at three facilities that manufacture ultrasound equipment and software for heart imaging and telehealth.
The FDA sent the warning letter to Philips on Sept. 9 and posted it on Tuesday. The communication followed inspections in early 2025 of three facilities in Washington, Pennsylvania and the Netherlands.
The FDA raised concerns with Philips’ process for handling complaints and device corrections. Philips has tasked a specific unit with handling complaints, but the company lacks documentation to show that complaints are being evaluated.
For example, Philips received a complaint in 2023 with conflicting information about an ultrasound probe breaking in half; however, the file did not show that the company investigated the event.
Another complaint was filed in 2024, reporting performance problems with a transesophageal ultrasound transducer in three different exams. The report was closed and documented as a non-complaint, according to the warning letter, but it should have been recorded as a complaint.
The FDA letter also raised problems with transducers being refurbished and sent to customers beyond their three-year useful life. The FDA said it observed seven transducers that were refurbished in this way and were associated with complaints.
Finally, the letter mentions Philips failing to send reports to the FDA within 10 days of a device correction or removal. For example, Philips sent a communication to customers in 2022, warning them of a voltage problem that could damage the transducer over time. Philips fixed the software defect; however, the company did not submit a report of the action to the FDA.
A Philips spokesperson wrote in an emailed statement that Philips is working on a multi-year program to enhance its quality system and address historical issues. The spokesperson said nine of Philips’ global facilities underwent FDA inspections in early 2025, and three of the inspections led to observations related to Philips’ documentation, processes and procedures.
Philips has already taken action to address the FDA’s earlier observations, the spokesperson said, and the products mentioned in the warning letter continue to be manufactured and sold.
Philips does not expect any material impact from the warning letter.
