FDA 483 - PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - February 05, 2016

Philips Medical Systems Nederlands, a device manufacturer in Best, Netherlands, was cited for two observations during an FDA inspection. The firm failed to maintain adequate records of electronic product radiation safety test results, specifically for a failed performance test of their Allura Xper FD20/15 system. Additionally, the company did not immediately report accidental radiation occurrences (AROs) to the FDA's CDRH within the required timeframe.