Device brand name · System x-ray angiographic

Allura Xper FD10/10: medical device reports filed with FDA

327 reports name it, 2009–2026. Manufacturer given most often on reports: Philips Medical Systems Nederland. Product code IZI.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

327
device reports naming the brand: 0% of all MAUDE reports · about 19 a year; 111
reports, 12 months to August 2026: 59 in the 12 months before; 98.5%
classified as malfunction: 94.3% across the product code; 0.3%
classified as death, as reported: 1 reports · not verified by FDA

327 medical device reports received by FDA name the brand "Allura Xper FD10/10" (system x-ray angiographic); the manufacturer given most often on reports is Philips Medical Systems Nederland; received from August 2009 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

111 reports arrived in the 12 months to August 2026, up 88% from 59 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 (98.5%), injury (1.2%) and death (0.3%); 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 (37%), radiation output failure (23.9%) and no display/image (9.2%). The patient problems coded most often are death, fall and myocardial infarction. 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

Death0.3%1

Injury1.2%4

Malfunction98.5%322

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%327

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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	121	37%	32.3%
Radiation output failure	78	23.9%	25.1%
No display/image	30	9.2%	6.6%
Positioning failure	27	8.3%	10.1%
No device output	5	1.5%	2.1%
Unintended system motionthe device moved when it should not have	4	1.2%	1.3%
Detachment of device or device componentpart of the device came off	3	0.9%	0.6%
Device operates differently than expectedthe device behaved unexpectedly	3	0.9%	3.4%
Application interface becomes non-functional or program exits abnormally	2	0.6%	0.7%
Device alarm system	2	0.6%	0.1%
Device inoperablethe device could not be used	2	0.6%	1.3%
Difficult or delayed activation	2	0.6%	0.2%
Display or visual feedback problem	2	0.6%	0.3%
Failure to power up	2	0.6%	1.2%
Insufficient device problem information	2	0.6%	1.2%
Loss of powerthe device lost power	2	0.6%	1.5%
Breakthe device broke	1	0.3%	0.5%
Device displays incorrect message	1	0.3%	1.8%
Image orientation incorrect	1	0.3%	0.1%
Loss of or failure to bond	1	0.3%	0%

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	1	0.3%
Falla fall	1	0.3%
Myocardial infarctionheart attack	1	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Allura Xper FD10/10	Product code IZI	All MAUDE reports
Reports	327	7,711	26,136,888
Share of that pool	—	4.2%	0%
Classified as death, per 1,000 reports	3	11	9
Classified as injury	1.2%	3.4%	36.2%
Classified as malfunction	98.5%	94.3%	62.3%
Filed by the manufacturer	100%	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	1,328	404	1.3%
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 FD10/10 reports

How many FDA reports name Allura Xper FD10/10?

327 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 111 in the latest 12 months.

What kinds of events are reported?

malfunction (98.5%), injury (1.2%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

activation failure (37%), radiation output failure (23.9%), no display/image (9.2%), positioning failure (8.3%) and no device output (1.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Allura Xper FD10/10 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.