The U.S. Food and Drug Administration recently handed down a warning to Royal Philips for failing to appropriately address manufacturing issues related to some of the company’s imaging equipment.
Following an October 2023 inspection of Philips’ facility in Suzhou, China, authorities determined that some of the company’s CT and ultrasound systems were “adulterated.” The FDA noted that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the current good manufacturing practice requirements."
Specifically, Philips did not publicly report corrections that had been made to its Incisive CT machines. These modifications pertained to cable connection issues and software defects that can result in artifacts or images being flipped, reversed or altered in other ways.
Both issues, the U.S. FDA noted, could cause delays or misdiagnoses, both of which pose risks to patient health.
Philips last responded to the inspection findings in December. However, that response was deemed “not adequate” by the FDA. Further, in a warning letter sent to Philips in February regarding the corrections, the FDA revealed that, since their initial inspection, the agency had received an additional 19 reports for recalls of other radiology devices manufactured by the company.
With that in mind, the FDA recommended that Philips extend its own retrospective inspections beyond two years to ensure that no additional field actions are missed.
In an emailed statement to Health Imaging, Philips spokesperson Steve Klink confirmed that the recommended inspection window had been extended. He also emphasized that none of the observations made in the inspections have involved instances of patient harm. The extended inspection is not expected to cause any issues in production or shipments, Klink said.
Steve C. de Baca, chief patient safety and quality officer of Philips, also commented on the matter.
"Patient safety and quality is Philips’ highest priority, and we have intensified our efforts to strengthen patient safety and quality management across the company," he said in an emailed statement. "We will address any identified quality management issues thoroughly and transparently, ensuring proper coordination with the relevant global competent authorities and regulators. We are working closely with the FDA to address the matters raised in the warning letter and are committed to completing the necessary actions in a timely manner.”
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.