FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 22529546
·
Received July 17, 2025
Report
- Report Number
- 3003768277-2025-006482
- Event Type
- Malfunction
- Date Received
- July 17, 2025
- Date of Event
- September 6, 2021
- Report Date
- July 17, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838059030
- PMA / PMN Number
- K130638
- Removal / Correction Number
- C&R#: 3003768277-12/28/
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)) AND IS RELATED TO AND OCCURRED PRIOR TO (C&R#: 3003768277-12/28/2023-011-C).
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT MACHINE IS NOT BOOTING. THE IS CONNECTED TO A STARTUP ISSUE RELATED TO A ALLURA XPER FD10. THERE WAS NO REPORTED PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565990 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD10 | 00884838059030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |