# FDA 483 - Siemens Medical Solutions USA, Inc. - January 31, 2024

Source: https://www.keypedia.com/records/483/siemens-medical-solutions-usa-inc/e1a64a29-9e2f-4ba9-abf7-926880f42880

> FDA 483 for Siemens Medical Solutions USA, Inc. on January 31, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Siemens Medical Solutions USA, Inc.
- Inspection Date: 2024-01-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Siemens Medical Solutions USA, Inc. in Issaquah, WA, was inspected from January 23-31, 2024, and received a Form 483 for inadequate complaint handling procedures. The firm failed to properly escalate potential product issues related to its Class II ACUSON Diagnostic Imaging Systems to the Designated Complaint Unit, indicating a breakdown in their complaint management system.

## Related Documents

- [483 - 2023-01-06](https://www.keypedia.com/records/483/siemens-medical-solutions-usa-inc/6fa6528a-38e9-4aa4-aa9e-c769792169dc)

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/siemens-medical-solutions-usa-inc/d1fd6cea-59f9-4236-8f53-b34f9294fde4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822