System, x-ray, angiographic: medical device reports filed with FDA

7,711 reports carry this product code, 1994–2026; 12 brands with a page.

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.

7,711
reports with this product code: 0% of all MAUDE reports; 1,841
reports, 12 months to August 2026: 1,670 in the 12 months before; 94.3%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

Product code IZI is FDA's classification for "System, x-ray, angiographic" (radiology panel), a class 2 device. 7,711 medical device reports carry this product code, 0% of the MAUDE database, from August 1994 to August 2026.

1,841 reports arrived in the 12 months to August 2026, up 10% from 1,670 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 (94.3%), injury (3.4%) and death (1.1%). 12 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Allura Xper FD	4,479	5,580	0.1%	99.6%
Allura Xper FD10	1,296	404	1.3%	96%
Allura Xper FD10/10	215	111	0.3%	98.5%
Allura Xper FD20	209	676	0.6%	95.7%
Artis zee biplane	60	7	1.1%	92.9%
EndoWrist SP	23	597	0%	85.7%
Artis Zee Ceiling	19	4	0.5%	95.7%
Artis zee floor	9	6	3.4%	92.2%
Innova	7	32	0.7%	53.1%
Toshiba	6	0	1.9%	28.5%
Azurion	3	3,673	0.1%	99.2%
Itrak 3500	1	0	0%	100%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Philips Medical Systems Nederland	5,806	75.3%
Philips Healthcare	578	7.5%
Philips Medical Systems	406	5.3%
Siemens Healthcare	66	0.9%
Ge Medical Systems	59	0.8%
Siemens Medical Solutions USA	56	0.7%
Intuitive Surgical	23	0.3%
Ge Healthcare	15	0.2%
Olympus Medical Systems Hinode Plant	2	0%
Biosense Webster	1	0%
Ge Oec Medical Systems	1	0%
Ge Oec Medical Systems Slc	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.1%86

Injury3.4%264

Malfunction94.3%7,269

Other0.9%66

Not given0.3%26

Who filed

Manufacturer report96.9%7,473

Voluntary report1%74

User facility report0%0

Distributor report0.2%17

Not given1.9%147

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Activation failure	2,487	32.3%
Radiation output failure	1,934	25.1%
Positioning failure	779	10.1%
No display/image	509	6.6%
Device operates differently than expectedthe device behaved unexpectedly	261	3.4%
No device output	162	2.1%
Device displays incorrect message	142	1.8%
Loss of powerthe device lost power	115	1.5%
Device inoperablethe device could not be used	104	1.3%
Unintended system motionthe device moved when it should not have	99	1.3%
Failure to power up	92	1.2%
Insufficient device problem information	89	1.2%
Component falling	82	1.1%
Self-activation or keying	59	0.8%
Device issuea problem with the device	55	0.7%
Application interface becomes non-functional or program exits abnormally	53	0.7%
Detachment of device or device componentpart of the device came off	43	0.6%
Poor quality image	43	0.6%
Breakthe device broke	39	0.5%
Image display error/artifact	39	0.5%

Questions about system, x-ray, angiographic reports

What is product code IZI?

FDA's classification code for "System, x-ray, angiographic", class 2, reviewed by the radiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

7,711 reports through August 2026, 1,841 of them in the latest 12 months.

Which brands appear most often?

Allura Xper FD (4,479), Allura Xper FD10 (1,296), Allura Xper FD10/10 (215), Allura Xper FD20 (209) and Artis zee biplane (60). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.