Philips Gets Warning Letter for CT Manufacturing Site in China

Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning Letter citing the risks of malfunctioning of cable connection failure and software defects.

The agency inspected Philips’ facility Oct. 23-26, 2023, where the company manufactures computed tomography (CT) and ultrasound systems.

Noting 64 complaints of cable connection issues, the letter states that Philips failed to ensure its supplier’s validation of the injection molding process for its CT patient interface monitor (PIM). The cable was redesigned, and a field correction conducted, the letter says, because “The cable connection failure led to ECG gating signal loss/error, which could cause a potential rescan and delay in diagnosis.”

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