FEI 2518586
Philips Ultrasound Llc
1 Echo Dr, Reedsville, PA, US
MDR events16All time
Recalls2All time
Registered products6
Establishment typeManufactureManufacture Medical Device
Registered product codes
6 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 2518586.
FDA inspections
2 on file
- Official Action Indicated (OAI)Mar 13, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Mar 13, 2025
Radiation Control and Health Safety Act · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50(a)(2)Mar 13, 2025
Supplier oversight
- 21 CFR 820.100(a)Mar 13, 2025
Lack of or inadequate procedures
- 21 CFR 820.160(a)Mar 13, 2025
Lack of or inadequate procedures for distribution
- 21 CFR 820.198(a)Mar 13, 2025
Complaints
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.