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

5,268 reports carry this product code, 1993–2026; 15 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.

5,268
reports with this product code: 0% of all MAUDE reports; 225
reports, 12 months to August 2026: 217 in the 12 months before; 54.1%
classified as malfunction: 62.3% across all reports; 4.2%
classified as death, as reported: 0.9% across all reports

Product code JAK is FDA's classification for "System, x-ray, tomography, computed" (radiology panel), a class 2 device. 5,268 medical device reports carry this product code, 0% of the MAUDE database, from April 1993 to August 2026.

225 reports arrived in the 12 months to August 2026, close to the 217 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 (54.1%), injury (28.9%) and death (4.2%). 15 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
Superdimension Inreach System	398	0	26.6%	26.4%
Illumisite	380	70	0.5%	57.1%
Brilliance 64	357	0	0.6%	58%
Brilliance 16 Air	249	0	0.4%	78.7%
Ict	222	0	0.5%	96.4%
Superdimension Inreach Bronchus System	210	0	14.1%	15%
Superdimension	192	5	7%	12.3%
Edge	73	171	0.1%	88.6%
Toshiba	37	0	1.9%	28.5%
Acist	6	14	10.6%	14.9%
Philips	3	0	6.3%	78.9%
Artis zee biplane	1	7	1.1%	92.9%
Artis Zee Ceiling	1	4	0.5%	95.7%
Bd Vacutainer Push Button Blood Collection Set With Pre-Attached Holder	1	0	0%	97.6%
BD Vacutainer Safety-Lok Blood Collection Set	1	144	0%	81.7%

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 Cleveland	1,584	30.1%
Covidien - Superdimension	700	13.3%
Ge Medical Systems	287	5.4%
Siemens Healthcare	196	3.7%
Philips Medical Systems Nederland	57	1.1%
Siemens Medical Solutions USA	54	1%
Ge Healthcare	24	0.5%
Philips Medical Systems	24	0.5%
Philips Healthcare	16	0.3%
Philips Ultrasound	3	0.1%
Ge Oec Medical Systems	2	0%
Becton Dickinson & Bd	1	0%
Medtronic Navigation Littleton	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

Death4.2%219

Injury28.9%1,522

Malfunction54.1%2,852

Other2.1%112

Not given10.7%563

Who filed

Manufacturer report89.7%4,725

Voluntary report5%263

User facility report0%0

Distributor report0.9%49

Not given4.4%231

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

Device problems coded

Device problem (FDA code)	Reports	Share
Signal artifact/noise	481	9.1%
Device operates differently than expectedthe device behaved unexpectedly	467	8.9%
Device displays incorrect message	330	6.3%
Degraded	294	5.6%
Insufficient device problem information	288	5.5%
Application program problem	198	3.8%
Mechanical problema mechanical problem	183	3.5%
Unintended system motionthe device moved when it should not have	152	2.9%
Improper or incorrect procedure or method	151	2.9%
Unintended movement	133	2.5%
Patient data problem	128	2.4%
Breakthe device broke	114	2.2%
Computer software problema software problem	110	2.1%
Image display error/artifact	100	1.9%
Sticking	93	1.8%
Device operational issue	90	1.7%
Display or visual feedback problem	88	1.7%
Detachment of device component	77	1.5%
Connection problema connection problem	69	1.3%
Communication or transmission problemthe device could not communicate or transmit	67	1.3%

Questions about system, x-ray, tomography, computed reports

What is product code JAK?

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

How many reports carry this code?

5,268 reports through August 2026, 225 of them in the latest 12 months.

Which brands appear most often?

Superdimension Inreach System (398), Illumisite (380), Brilliance 64 (357), Brilliance 16 Air (249) and Ict (222). 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.