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

Source: https://www.globalkeysolutions.net/records/483/philips-medical-systems-dmc-gmbh/839fdbbd-1a23-4760-b5d9-a09b488e8b2e

> FDA 483 for Philips Medical Systems DMC GmbH on January 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Medical Systems DMC GmbH
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems-dmc-gmbh/78164a38-f997-43ff-8470-20686ac91ad1

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd