FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 23233053
·
Received October 7, 2025
Report
- Report Number
- 3003768277-2025-011359
- Event Type
- Malfunction
- Date Received
- October 7, 2025
- Date of Event
- July 22, 2021
- Report Date
- October 7, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- PMA / PMN Number
- K162859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PHILIPS SERVICE REPLACED THE FORCE SENSOR AND NODE INTERFACE UNIT, TESTED THE SYSTEM, AND RETURNED IT TO USE. THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE:(B)(4)).
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT GANTRY MOVEMENT FAILURE DUE TO FORCE SENSOR AND NIU ISSUES ON A ALLURA XPER FD10. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2614580 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |