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

Source: https://www.keypedia.com/records/483/philips-medical-systems-nederland-bv/035f02c5-83f4-4009-84ca-fe1b4630639c

> FDA 483 for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on February 05, 2016. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Inspection Date: 2016-02-05
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Summary: During an inspection conducted from February 1 to February 5, 2016, the FDA observed significant issues at Philips Medical Systems Nederlands, a device manufacturer located in Best, Netherlands. The inspection, documented in a Form FDA 483, highlighted two primary concerns related to regulatory compliance for their Class II Allura Xper FD20/15 system. Firstly, the firm failed to adequately maintain records for electronic product radiation safety tests. Specifically, a performance test for the Allura Xper FD20/15 system, which failed to meet manufacturing specifications related to radiation emission on September 30, 2015, was not properly documented. This suggests a lapse in quality control and record-keeping practices essential for device safety. Secondly, Philips Medical Systems Nederlands did not report accidental radiation occurrences (AROs) to the FDA's Center for Devices and Radiological Health (CDRH) within the required timeframe. Multiple instances were cited where AROs, some known for several months, experienced significant reporting delays, including one case with a 212-day delay. This indicates a failure to adhere to critical post-market surveillance and reporting obligations aimed at ensuring public safety. The company is now required to address these observations by implementing comprehensive corrective actions to ensure compliance with federal regulations governing medical device manufacturing and radiation safety. This includes improving documentation practices and streamlining the reporting of adverse events.

## Related Documents

- [483 - 2016-02-05](https://www.keypedia.com/records/483/philips-medical-systems-nederland-bv/25de1a3e-1245-4c68-bd4a-9c8a76c4a8ba)

## Related Officers

- [General Manager](https://www.keypedia.com/people/bert-van-meurs/b3bdc40e-138f-4d78-a152-6e4d9c7b185c)
- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/philips-medical-systems-nederland-bv/667b13ad-6e74-4448-9805-0b13c8c26e46

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7