GE OEC Medical Systems, Inc
⚠️ Moderate Risk
FEI: 1720753 • Salt Lake City, UT • UNITED STATES
FEI Number
1720753
Location
Salt Lake City, UT
Country
UNITED STATESAddress
384 N Wright Brothers Dr, , Salt Lake City, UT, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/27/2024 | 90RCCC-ARM FLUOROSCOPIC X-RAY SYSTEM, MEDICAL DIAGNOSTIC X-RAY EQUIPMENT | Division of Northeast Imports (DNEI) | |
| 6/29/2015 | 90JAASYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 11/5/2014 | 90OXOIMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/27/2009 | 90JAASYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is GE OEC Medical Systems, Inc's FDA import refusal history?
GE OEC Medical Systems, Inc (FEI: 1720753) has 4 FDA import refusal record(s) in our database, spanning from 3/27/2009 to 11/27/2024.
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, Inc's FEI number is 1720753.
What types of violations has GE OEC Medical Systems, Inc received?
GE OEC Medical Systems, Inc 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 OEC Medical Systems, Inc come from?
All FDA import refusal data for GE OEC Medical Systems, Inc 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.