Devices › System, x-ray, angiographic
Device brand name · System x-ray angiographic
Allura Xper FD10: medical device reports filed with FDA
1,328 reports name it, 2007–2026. Manufacturer given most often on reports: Philips Medical Systems Nederland. Product code IZI.
- 1,328
- device reports naming the brand
- 0% of all MAUDE reports · about 70 a year
- 404
- reports, 12 months to August 2026
- 201 in the 12 months before
- 96%
- classified as malfunction
- 94.3% across the product code
- 1.3%
- classified as death, as reported
- 17 reports · not verified by FDA
1,328 medical device reports received by FDA name the brand "Allura Xper FD10" (system x-ray angiographic); the manufacturer given most often on reports is Philips Medical Systems Nederland; received from June 2007 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
404 reports arrived in the 12 months to August 2026, up 101% from 201 in 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 (96%), injury (2.6%) and death (1.3%); across all system, x-ray, angiographic reports (product code IZI) death is recorded in 1.1% and malfunction in 94.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation failure (32.3%), radiation output failure (24%) and positioning failure (12.3%). The patient problems coded most often are death, no patient involvement and burn(s). 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 7,711 reports carrying product code IZI. 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 | 429 | 32.3% | 32.3% |
| Radiation output failure | 319 | 24% | 25.1% |
| Positioning failure | 163 | 12.3% | 10.1% |
| No display/image | 126 | 9.5% | 6.6% |
| No device output | 30 | 2.3% | 2.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 28 | 2.1% | 3.4% |
| Loss of powerthe device lost power | 23 | 1.7% | 1.5% |
| Device inoperablethe device could not be used | 20 | 1.5% | 1.3% |
| Unintended system motionthe device moved when it should not have | 18 | 1.4% | 1.3% |
| Device displays incorrect message | 16 | 1.2% | 1.8% |
| Bent | 13 | 1% | 0.4% |
| Application interface becomes non-functional or program exits abnormally | 11 | 0.8% | 0.7% |
| Detachment of device or device componentpart of the device came off | 10 | 0.8% | 0.6% |
| Failure to power up | 10 | 0.8% | 1.2% |
| Smoking | 10 | 0.8% | 0.5% |
| Display or visual feedback problem | 7 | 0.5% | 0.3% |
| Breakthe device broke | 6 | 0.5% | 0.5% |
| Computer operating system problem | 6 | 0.5% | 0.5% |
| Device stops intermittentlythe device stopped now and then | 6 | 0.5% | 0.3% |
| Insufficient device problem information | 6 | 0.5% | 1.2% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 16 | 1.2% |
| No patient involvement | 9 | 0.7% |
| Burn(s)a burn | 8 | 0.6% |
| Injurya physical injury | 3 | 0.2% |
| Laceration(s) | 3 | 0.2% |
| Painpain, site not specified | 3 | 0.2% |
| Radiation exposure, unintended | 2 | 0.2% |
| Radiation overdose | 2 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.1% |
| Bruise/contusion | 1 | 0.1% |
| Complaint, ill-defined | 1 | 0.1% |
| Falla fall | 1 | 0.1% |
| Hair loss | 1 | 0.1% |
| Head injurya head injury | 1 | 0.1% |
| Myocardial infarctionheart attack | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Allura Xper FD10 | Product code IZI | All MAUDE reports |
|---|---|---|---|
| Reports | 1,328 | 7,711 | 26,136,888 |
| Share of that pool | — | 17.2% | 0% |
| Classified as death, per 1,000 reports | 13 | 11 | 9 |
| Classified as injury | 2.6% | 3.4% | 36.2% |
| Classified as malfunction | 96% | 94.3% | 62.3% |
| Filed by the manufacturer | 99.4% | 96.9% | 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 IZI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Allura Xper FD | 20,061 | 5,580 | 0.1% |
| Allura Xper FD10/10 | 327 | 111 | 0.3% |
| Allura Xper FD20 | 2,179 | 676 | 0.6% |
| Artis zee biplane | 182 | 7 | 1.1% |
| EndoWrist SP | 1,355 | 597 | 0% |
| Artis Zee Ceiling | 209 | 4 | 0.5% |
| Artis zee floor | 232 | 6 | 3.4% |
| Innova | 868 | 32 | 0.7% |
| Toshiba | 158 | 0 | 1.9% |
| Azurion | 10,988 | 3,673 | 0.1% |
| Itrak 3500 | 235 | 0 | 0% |
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 Allura Xper FD10 reports
How many FDA reports name Allura Xper FD10?
1,328 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 404 in the latest 12 months.
What kinds of events are reported?
malfunction (96%), injury (2.6%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (32.3%), radiation output failure (24%), positioning failure (12.3%), no display/image (9.5%) and no device output (2.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and distributor reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Allura Xper FD10 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.