Ge Healthcare Logistique France

⚠️ High Risk

FEI: 3005216789 • Cedex • FRANCE

FEI

FEI Number

3005216789

📍

Location

Cedex

🇫🇷

Country

FRANCE

🏢

Address

Bat. Amb Zac Paris Nord 2rue Des, , Cedex, , France

High Risk

FDA Import Risk Assessment

50.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

3/8/2006

Latest Refusal

7/13/2005

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

67.9×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

34167×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

50867×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
3/8/2006	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2006	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2006	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2006	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/8/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/8/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/8/2006	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/8/2006	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/5/2006	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/5/2006	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/5/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/8/2005	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/8/2005	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/8/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/1/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/1/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/1/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/1/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/1/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/1/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Ge Healthcare Logistique France's FDA import refusal history?

Ge Healthcare Logistique France (FEI: 3005216789) has 67 FDA import refusal record(s) in our database, spanning from 7/13/2005 to 3/8/2006.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Ge Healthcare Logistique France's FEI number is 3005216789.

What types of violations has Ge Healthcare Logistique France received?

Ge Healthcare Logistique France has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Ge Healthcare Logistique France come from?

All FDA import refusal data for Ge Healthcare Logistique France is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.