Dive Brief:

• The Food and Drug Administration identified problems with a Royal Philips facility that makes computed tomography (CT) and ultrasonography systems, the agency said in a warning letter posted Tuesday. 
• The warning letter was sent to Philips in February after an inspection of its manufacturing facility in Suzhou, China, in October 2023. The FDA said the devices were adulterated for not conforming to good manufacturing practice requirements.
• Specifically, the FDA found Philips failed to validate an injection molding process for a custom-manufactured data cable used in its Incisive CT machines, and the company failed to report past field corrections to the agency.

Dive Insight:

Philips currently faces multiple regulatory challenges related to its handling of device recalls. The company must stop selling some of its sleep and respiratory devices in the U.S. amid a massive global recall, per the terms of a consent decree, and previously received a warning letter for not submitting medical device reports related to malfunctions with its Trilogy ventilators.

Now, the company is grappling with concerns related to some of its radiology devices outlined in a new warning letter. 

The FDA inspected a manufacturing facility in Suzhou, China, from Oct. 23 to Oct. 26. Inspectors found that Philips failed to report to the FDA three field corrections related to its Incisive CT machines. 

One of the problems was a cable connection failure with the CT patient interface monitor, which could cause a delay in diagnosis. The other two involved software defects that could cause reversed or upside-down images, or image artifacts, which could cause misdiagnosis. 

The FDA posted a related recall in January, saying the software defect impacted 828 devices worldwide. Philips sent the notice to customers in December 2022. 

Additionally, the FDA found 19 other reports for recalls of other Philips radiology devices, according to the warning letter.

Philips responded with a retrospective review saying the three unreported field corrections were the only recalls it was required to report. However, the FDA found other reports from older recalls, such as a problem with Philips’ Insignia MR device losing system access for days after power outages. 

“While your firm's retrospective review covers the last two years, given the previously unreported recalls identified, a further lookback (beyond two years) is advised to ensure there are no additional field actions that require a report of correction and removal,” the FDA said in the warning letter. 

The agency added that Philips failed to ensure validation of an injection molding process used by the company’s supplier of custom-manufactured Incisive CT Patient Interface Monitor data cables. The cable was redesigned after 64 complaints of cable connection issues. 

“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,” Steve C de Baca, Philips’ chief patient safety and quality officer, wrote in an emailed statement. 

Philips spokesperson Steve Klink wrote in an email that the warning letter advised the company to extend the timeframe of a review of field safety notices and a review of all parts supplied to Suzhou. The inspection observations did not include reports of patient harm, he wrote. 

The Philips Suzhou team does not anticipate any production or shipment disruptions or a material financial impact, Klink added. The Suzhou facility primarily supplies markets outside of the U.S.