System, x-ray, fluoroscopic, image-intensified: medical device reports filed with FDA

90,607 reports carry this product code, 1992–2026; 28 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.

90,607
reports with this product code: 0.4% of all MAUDE reports; 33
reports, 12 months to August 2026: 29 in the 12 months before; 99.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code JAA is FDA's classification for "System, x-ray, fluoroscopic, image-intensified" (radiology panel), a class 2 device. 90,607 medical device reports carry this product code, 0.4% of the MAUDE database, from February 1992 to July 2026.

33 reports arrived in the 12 months to August 2026, up 14% from 29 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 (99.5%), injury (0.2%) and other (0.1%). 28 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
Ge Oec 9800	8,504	0	0%	99.7%
Ge Oec 9900	3,245	0	0%	99.9%
Ge Oec 9600	2,041	0	0%	99.8%
Stenoscop	1,869	0	0%	100%
Ge Oec 2800	750	0	0%	99.7%
Ge Oec 6800	750	0	0%	99.7%
Stenoscope	690	0	0%	100%
Ge Oec 2600	543	0	0%	99.4%
Ge Oec 8800	404	0	0%	100%
Oec 9800	330	0	0%	100%
Fluorostar	304	0	0%	100%
C-Arm	273	4	0%	98.5%
Ge Oec 6600	273	0	0%	100%
Ge Oec 9900 Elite	191	0	0.5%	99%
Oec 9900	187	0	0%	100%
Entrak 2500	23	0	0%	100%
Itrak 3500	14	0	0%	100%
Toshiba	13	0	1.9%	28.5%
O-Arm O2 Imaging System	8	681	0.1%	99%
Innova	2	32	0.7%	53.1%
Philips	2	0	6.3%	78.9%
Allura Xper FD10	1	404	1.3%	96%
Inratio	1	0	0.1%	85.8%
O-Arm 1000 Imaging System	1	2	0%	98.6%
O-Arm Imaging System	1	44	1.5%	63.9%
Precision?	1	446	0.4%	15.7%
Quantum	1	35	0.5%	66.7%
St104 Transport	1	4	0%	95.6%

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
Ge Oec Medical Systems Slc	46,816	51.7%
Ge Oec Medical Systems	39,719	43.8%
Ge Medical Systems India Private	1,000	1.1%
Ge Medical Systems	161	0.2%
Siemens Healthcare	100	0.1%
Philips Medical Systems	59	0.1%
Philips Healthcare	56	0.1%
Siemens Medical Solutions USA	47	0.1%
Ge Healthcare	19	0%
Philips Medical Systems Nederland	17	0%
Hologic	14	0%
Medtronic Navigation Littleton	10	0%
Deroyal Industries	2	0%
Liebel-Flarsheim	2	0%
Biosense Webster	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%20

Injury0.2%220

Malfunction99.5%90,160

Other0.1%81

Not given0.1%126

Who filed

Manufacturer report99.5%90,167

Voluntary report0.2%153

User facility report0%0

Distributor report0%7

Not given0.3%280

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device displays incorrect message	22,314	24.6%
Computer operating system problem	15,718	17.3%
No display/image	9,696	10.7%
No device output	6,743	7.4%
Device operates differently than expectedthe device behaved unexpectedly	5,212	5.8%
Device inoperablethe device could not be used	4,490	5%
Application interface becomes non-functional or program exits abnormally	4,104	4.5%
Poor quality image	3,689	4.1%
Failure to power up	3,515	3.9%
Loss of powerthe device lost power	3,037	3.4%
Computer failure	2,954	3.3%
Sticking	2,950	3.3%
Device issuea problem with the device	2,341	2.6%
Image resolution poor	1,833	2%
Device stops intermittentlythe device stopped now and then	1,668	1.8%
Repair	1,404	1.5%
Failure, intermittent	1,388	1.5%
Self-activation or keying	1,362	1.5%
Failure to back-up	1,325	1.5%
Image display error/artifact	1,277	1.4%

Questions about system, x-ray, fluoroscopic, image-intensified reports

What is product code JAA?

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

How many reports carry this code?

90,607 reports through August 2026, 33 of them in the latest 12 months.

Which brands appear most often?

Ge Oec 9800 (8,504), Ge Oec 9900 (3,245), Ge Oec 9600 (2,041), Stenoscop (1,869) and Ge Oec 2800 (750). 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.