Philips Ultrasound, LLC
⚠️ Moderate Risk
FEI: 3019216 • Bothell, WA • UNITED STATES
FEI Number
3019216
Location
Bothell, WA
Country
UNITED STATESAddress
22100 Bothell Everett Hwy, , Bothell, WA, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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 |
|---|---|---|---|
| 9/1/2023 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 11/27/2019 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Northern Border Imports (DNBI) | |
| 4/2/2019 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 3/7/2019 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of West Coast Imports (DWCI) | |
| 1/16/2019 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of West Coast Imports (DWCI) | |
| 10/23/2018 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/21/2018 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of West Coast Imports (DWCI) | |
| 9/18/2018 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of West Coast Imports (DWCI) | |
| 9/18/2018 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of West Coast Imports (DWCI) | |
| 9/1/2017 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Northern Border Imports (DNBI) | |
| 9/1/2017 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Northern Border Imports (DNBI) | |
| 9/1/2017 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Northern Border Imports (DNBI) | |
| 9/1/2017 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Northern Border Imports (DNBI) | |
| 10/24/2016 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Southwest Imports (DSWI) | |
| 12/29/2015 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | New Orleans District Office (NOL-DO) | |
| 11/20/2015 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | New Orleans District Office (NOL-DO) | |
| 11/20/2015 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | New Orleans District Office (NOL-DO) | |
| 1/29/2015 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 1/29/2015 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 10/31/2013 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 10/31/2013 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 10/24/2013 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | New Orleans District Office (NOL-DO) | |
| 8/3/2012 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Chicago District Office (CHI-DO) | |
| 6/14/2010 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 341REGISTERED | Detroit District Office (DET-DO) |
| 10/16/2009 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Florida District Office (FLA-DO) | |
| 7/7/2006 | 85KNGMONITOR, ULTRASONIC, FETAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Philips Ultrasound, LLC's FDA import refusal history?
Philips Ultrasound, LLC (FEI: 3019216) has 27 FDA import refusal record(s) in our database, spanning from 7/7/2006 to 9/1/2023.
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. Philips Ultrasound, LLC's FEI number is 3019216.
What types of violations has Philips Ultrasound, LLC received?
Philips Ultrasound, LLC has been cited for 7 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 Philips Ultrasound, LLC come from?
All FDA import refusal data for Philips Ultrasound, LLC 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.