# FDA 483 - GE Medical Systems Information Technologies, Inc. - July 19, 2018

Source: https://www.globalkeysolutions.net/records/483/ge-medical-systems-information-technologies-inc/60cf6439-7dcc-434d-afd5-86eacbb2b120

> FDA 483 for GE Medical Systems Information Technologies, Inc. on July 19, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GE Medical Systems Information Technologies, Inc.
- Inspection Date: 2018-07-19
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: GE Medical Systems Information Technologies, Inc. in Milwaukee, WI, was cited with five observations during an FDA inspection from July 9-19, 2018. The inspection revealed significant deficiencies in device software validation, design verification, medical device reporting procedures, and corrective and preventive actions. Additionally, the firm failed to accurately report the total number of devices subject to a recall.

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)
- [Adaliz Santaliz-Cruz](https://www.globalkeysolutions.net/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)
- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.globalkeysolutions.net/companies/ge-medical-systems-information-technologies-inc/586be979-9267-4943-ab94-6fdae6fafc2d

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d