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GE OEC Medical Systems Gmbh

⚠️ Moderate Risk

FEI: 3003283350 • Wendelstein, Bavaria • GERMANY

FEI

FEI Number

3003283350

📍

Location

Wendelstein, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Wilhelm-Maisel-Str. 14, , Wendelstein, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
1/13/2008
Latest Refusal
1/13/2008
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
1/13/2008
90IZOGENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is GE OEC Medical Systems Gmbh's FDA import refusal history?

GE OEC Medical Systems Gmbh (FEI: 3003283350) has 1 FDA import refusal record(s) in our database, spanning from 1/13/2008 to 1/13/2008.

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 OEC Medical Systems Gmbh's FEI number is 3003283350.

What types of violations has GE OEC Medical Systems Gmbh received?

GE OEC Medical Systems Gmbh has been cited for 1 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 OEC Medical Systems Gmbh come from?

All FDA import refusal data for GE OEC Medical Systems Gmbh 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.