Devices › Interventional fluoroscopic x-ray system
Device brand name · Interventional fluoroscopic x-ray system
Azurion: medical device reports filed with FDA
10,988 reports name it, 2020–2026. Manufacturer given most often on reports: Philips Medical Systems Nederland. Product code OWB.
- 10,988
- device reports naming the brand
- 0% of all MAUDE reports · about 1,913 a year
- 3,673
- reports, 12 months to August 2026
- 3,401 in the 12 months before
- 99.2%
- classified as malfunction
- 98.5% across the product code
- 0.1%
- classified as death, as reported
- 16 reports · not verified by FDA
FDA's MAUDE database holds 10,988 reports that name the brand "Azurion" (interventional fluoroscopic x-ray system), received between October 2020 and August 2026; the manufacturer given most often on reports is Philips Medical Systems Nederland. Spellings of one product vary from report to report.
3,673 reports arrived in the 12 months to August 2026, close to the 3,401 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (99.2%), injury (0.6%) and death (0.1%); across all interventional fluoroscopic x-ray system reports (product code OWB) death is recorded in 0.2% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation failure (39.2%), radiation output failure (34.6%) and positioning failure (15.3%). The patient problems coded most often are hair loss, cardiac arrest and needle stick/puncture. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 50,356 reports carrying product code OWB. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Activation failure | 4,302 | 39.2% | 25.5% |
| Radiation output failure | 3,804 | 34.6% | 21% |
| Positioning failure | 1,682 | 15.3% | 7.7% |
| No display/image | 646 | 5.9% | 4.3% |
| Detachment of device or device componentpart of the device came off | 132 | 1.2% | 0.7% |
| Unintended system motionthe device moved when it should not have | 116 | 1.1% | 0.6% |
| Failure to power up | 87 | 0.8% | 1.9% |
| Unexpected shutdown | 30 | 0.3% | 0.7% |
| Display or visual feedback problem | 22 | 0.2% | 0.7% |
| Poor quality image | 22 | 0.2% | 1.2% |
| Image display error/artifact | 19 | 0.2% | 0.7% |
| Insufficient device problem information | 16 | 0.1% | 0.7% |
| Smoking | 16 | 0.1% | 0.2% |
| Difficult or delayed activation | 15 | 0.1% | 0.1% |
| Erratic or intermittent display | 15 | 0.1% | 0.1% |
| No device output | 15 | 0.1% | 0.2% |
| Key or button unresponsive/not working | 13 | 0.1% | 0.1% |
| Mechanical jam | 11 | 0.1% | 0.1% |
| Activation problem | 10 | 0.1% | 0.1% |
| Difficult or delayed positioning | 8 | 0.1% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hair loss | 9 | 0.1% |
| Cardiac arrestthe heart stopped | 7 | 0.1% |
| Needle stick/puncture | 7 | 0.1% |
| Bruise/contusion | 6 | 0.1% |
| Crushing injury | 6 | 0.1% |
| Hemorrhage/blood loss/bleeding | 6 | 0.1% |
| Laceration(s) | 6 | 0.1% |
| Falla fall | 5 | 0% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0% |
| Ischemia | 4 | 0% |
| Bone fracture(s) | 3 | 0% |
| Foreign body in patientpart of a device left in the patient | 3 | 0% |
| Hemodynamic instability | 3 | 0% |
| Abrasion | 2 | 0% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Azurion | Product code OWB | All MAUDE reports |
|---|---|---|---|
| Reports | 10,988 | 50,356 | 26,136,888 |
| Share of that pool | — | 21.8% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 0.6% | 1.2% | 36.2% |
| Classified as malfunction | 99.2% | 98.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code OWB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Allura Xper FD | 20,061 | 5,580 | 0.1% |
| O-Arm O2 Imaging System | 10,979 | 681 | 0.1% |
| Allura Xper FD20 | 2,179 | 676 | 0.6% |
| Allura Xper FD20/10 & Allura Xper FD20/20 | 400 | 130 | 0.3% |
| O2 | 352 | 0 | 0.3% |
| Base Sys Bi70002000 O-Arm Sys O2 | 336 | 0 | 0% |
| Artis zee floor | 232 | 6 | 3.4% |
| Artis Zee Ceiling | 209 | 4 | 0.5% |
| O2 O-Arm Imaging System | 154 | 0 | 0% |
| O-Arm | 386 | 0 | 0% |
| Artis zee biplane | 182 | 7 | 1.1% |
| Allura Xper FD10/10 | 327 | 111 | 0.3% |
| O-Arm Imaging System | 396 | 44 | 1.5% |
| Allura Xper FD10 | 1,328 | 404 | 1.3% |
| Innova | 868 | 32 | 0.7% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Azurion reports
How many FDA reports name Azurion?
10,988 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3,673 in the latest 12 months.
What kinds of events are reported?
malfunction (99.2%), injury (0.6%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (39.2%), radiation output failure (34.6%), positioning failure (15.3%), no display/image (5.9%) and detachment of device or device component (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Azurion was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.