FDA 483 - Philips Medical Systems DMC GmbH - January 19, 2023

Philips Medical Systems DMC GmbH in Hamburg, Germany, a medical device manufacturer, was cited for two significant quality system deficiencies during an FDA inspection. Observations included failure to report a device risk involving X-ray systems with burning components and inadequate corrective and preventive action procedures. These issues indicate serious concerns regarding product safety and quality management.