FDA 483 - Philips Medical Systems Nederland B.V. - January 17, 2025

Philips Medical Systems Nederland B.V. was inspected regarding its medical device manufacturing operations. The inspection revealed significant deficiencies in reporting corrections and removals, conducting adequate risk analyses for its IntelliSpace Cardiovascular software, and establishing proper complaint handling procedures, including failures to report potential risks to the FDA and adequately escalate software defects. These issues are serious, as they involve allegations of patient harm and death related to software malfunctions.