Interventional fluoroscopic x-ray system: medical device reports filed with FDA

50,356 reports carry this product code, 2004–2026; 20 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.

50,356
reports with this product code: 0.2% of all MAUDE reports; 9,718
reports, 12 months to August 2026: 10,481 in the 12 months before; 98.5%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code OWB is FDA's classification for "Interventional fluoroscopic x-ray system" (radiology panel), a class 2 device. 50,356 medical device reports carry this product code, 0.2% of the MAUDE database, from September 2004 to August 2026.

9,718 reports arrived in the 12 months to August 2026, close to the 10,481 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 (98.5%), injury (1.2%) and death (0.2%). 20 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	15,579	5,580	0.1%	99.6%
Azurion	10,985	3,673	0.1%	99.2%
O-Arm O2 Imaging System	10,968	681	0.1%	99%
Allura Xper FD20	1,970	676	0.6%	95.7%
Allura Xper FD20/10 & Allura Xper FD20/20	400	130	0.3%	98%
O2	352	0	0.3%	98.9%
Base Sys Bi70002000 O-Arm Sys O2	335	0	0%	99.4%
Artis zee floor	223	6	3.4%	92.2%
Artis Zee Ceiling	189	4	0.5%	95.7%
O2 O-Arm Imaging System	154	0	0%	99.4%
O-Arm	133	0	0%	98.7%
Artis zee biplane	121	7	1.1%	92.9%
Allura Xper FD10/10	112	111	0.3%	98.5%
O-Arm Imaging System	41	44	1.5%	63.9%
Allura Xper FD10	31	404	1.3%	96%
Innova	29	32	0.7%	53.1%
Entrak 2500	3	0	0%	100%
O-Arm 1000 Imaging System	3	2	0%	98.6%
O-Arm 1000 Imaging System 3rd Edition	2	4	0%	99.1%
Ge Oec 9600	1	0	0%	99.8%

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	29,166	57.9%
Medtronic Navigation Littleton	6,953	13.8%
Ge Oec Medical Systems Slc	6,111	12.1%
Sanmina -Sci Systems	4,443	8.8%
Siemens Healthcare	820	1.6%
Philips Healthcare	258	0.5%
Ge Oec Medical Systems	96	0.2%
Medtronic Navigation	45	0.1%
Philips Medical Systems	42	0.1%
Ge Medical Systems	27	0.1%
Mazor Robotics	26	0.1%
Siemens Medical Solutions USA	24	0%
Medtronic Navigation Louisville	7	0%
Ge Healthcare	1	0%
Philips Electronics Nederland	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

Death0.2%108

Injury1.2%605

Malfunction98.5%49,577

Other0%5

Not given0.1%61

Who filed

Manufacturer report99.6%50,158

Voluntary report0.1%68

User facility report0%0

Distributor report0%4

Not given0.3%126

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

Device problems coded

Device problem (FDA code)	Reports	Share
Activation failure	12,824	25.5%
Radiation output failure	10,592	21%
Application program freezes or fails to launch	4,307	8.6%
Positioning failure	3,872	7.7%
Device inoperablethe device could not be used	3,710	7.4%
No display/image	2,141	4.3%
Device stops intermittentlythe device stopped now and then	1,711	3.4%
Device displays incorrect message	1,698	3.4%
Device operates differently than expectedthe device behaved unexpectedly	1,265	2.5%
Positioning problem	1,212	2.4%
Failure to advance	974	1.9%
Failure to power up	965	1.9%
Communication or transmission problemthe device could not communicate or transmit	857	1.7%
Noise, audible	791	1.6%
Device sensing problem	659	1.3%
Poor quality image	618	1.2%
Electrical /electronic property probleman electrical or electronic problem	556	1.1%
Mechanical problema mechanical problem	528	1%
Application program problem	475	0.9%
Application interface becomes non-functional or program exits abnormally	421	0.8%

Questions about interventional fluoroscopic x-ray system reports

What is product code OWB?

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

How many reports carry this code?

50,356 reports through August 2026, 9,718 of them in the latest 12 months.

Which brands appear most often?

Allura Xper FD (15,579), Azurion (10,985), O-Arm O2 Imaging System (10,968), Allura Xper FD20 (1,970) and Allura Xper FD20/10 & Allura Xper FD20/20 (400). 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.