FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 23567721
·
Received November 17, 2025
Report
- Report Number
- 3003768277-2025-014647
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- June 22, 2021
- Report Date
- November 17, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838054196
- PMA / PMN Number
- K162859
- Removal / Correction Number
- 3003768277-06/23/2023-00
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)) AND IS RELATED TO AND OCCURRED PRIOR TO 3003768277-06/23/2023-004-C.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT WIRELESS FOOT SWITCH NOT WORKING. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD10/10. THERE WAS NO REPORTED PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273417 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD10/10 | 00884838054196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |