Philips (PHG) Receives FDA Warning Letter Regarding CT Systems

Published on 26 Apr 2024 on Zacks via Yahoo Finance

Philips (PHG) Receives FDA Warning Letter Regarding CT Systems

Koninklijke Philips PHG recently received a warning letter from the FDA that outlines issues regarding imaging technology manufacturing practices in China for the Philips Incisive CT patient interface monitor (PIM).

The FDA found that the devices are "adulterated" after investigating the Suzhou, China, manufacturing plant. The inspection was conducted from Oct 23 to Oct 26, 2023. On Feb 23, 2024, Philips received a letter detailing the faults in the computed tomography (CT) systems manufacturing.

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