Philips Ultrasound Llc
22100 Bothell Everett Hwy, BOTHELL, WA, US
Registered product codes
9 product codes
Recent MDR events
16 on file
- PHILIPS X8-2T TEE TRANSDUCER XMATRIX TEE TRANSDUCERMar 16, 2026InjuryMW5185243
- TRANSDUCER X8-2TMar 3, 2026Malfunction24495255
- TEE PROBEJan 12, 2026Malfunction24031460
- PHILLIPSDec 23, 2025MalfunctionMW5181096
- IVUSJul 30, 2025MalfunctionMW5173542
- IVUSJun 17, 2025MalfunctionMW5171595
- IE33 DIAGNOSTIC ULTRASOUND SYSTEMApr 23, 2025Malfunction21890615
- EPIQ CVXFeb 11, 2025MalfunctionMW5165914
- TRANSDUCER X7-2TOct 17, 2024Malfunction20469847
- TRANSDUCER X8-2TAug 5, 2024Malfunction19905412
Recalls
2 on file
- CompletedDec 31, 2025
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
View FDA record ↗ - Open, ClassifiedDec 4, 2025
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
View FDA record ↗
Compliance history
Matched by FEI 3019216.
FDA inspections
3 on file
- Official Action Indicated (OAI)Jan 31, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Jan 31, 2025
Postmarket Assurance: Devices · Citations posted
- Official Action Indicated (OAI)Jan 31, 2025
Radiation Control and Health Safety Act · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
121 CFR 820.90(a)Nonconforming product control
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Complaints
121 CFR 820.198(d)Evaluation, timeliness, identification
1
- 21 CFR 820.50Jan 31, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(b)Jan 31, 2025
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Jan 31, 2025
Nonconforming product control
- 21 CFR 820.100(a)Jan 31, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jan 31, 2025
Complaints
- 21 CFR 820.198(d)Jan 31, 2025
Evaluation, timeliness, identification
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.