Devices › System, x-ray, tomography, computed
Device brand name · System x-ray tomography computed
Illumisite: medical device reports filed with FDA
380 reports name it, 2020–2026. Manufacturer given most often on reports: Covidien - Superdimension. Product code JAK.
- 380
- device reports naming the brand
- 0% of all MAUDE reports · about 59 a year
- 70
- reports, 12 months to August 2026
- 100 in the 12 months before
- 57.1%
- classified as malfunction
- 54.1% across the product code
- 0.5%
- classified as death, as reported
- 2 reports · not verified by FDA
380 medical device reports received by FDA name the brand "Illumisite" (system x-ray tomography computed); the manufacturer given most often on reports is Covidien - Superdimension; received from January 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
70 reports arrived in the 12 months to August 2026, down 30% from 100 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 (57.1%), injury (42.4%) and death (0.5%); across all system, x-ray, tomography, computed reports (product code JAK) death is recorded in 4.2% and malfunction in 54.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device displays incorrect message (52.4%), application program problem (25.3%) and patient data problem (13.9%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, pneumothorax and hemorrhage/blood loss/bleeding. 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
Who filed the report
Grey bar: all 5,268 reports carrying product code JAK. 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 |
|---|---|---|---|
| Device displays incorrect message | 199 | 52.4% | 6.3% |
| Application program problem | 96 | 25.3% | 3.8% |
| Patient data problem | 53 | 13.9% | 2.4% |
| Connection problema connection problem | 33 | 8.7% | 1.3% |
| Failure to advance | 26 | 6.8% | 0.8% |
| Material fragmentation | 19 | 5% | 1% |
| Application network problem | 17 | 4.5% | 0.9% |
| Breakthe device broke | 12 | 3.2% | 2.2% |
| Display or visual feedback problem | 12 | 3.2% | 1.7% |
| Communication or transmission problemthe device could not communicate or transmit | 10 | 2.6% | 1.3% |
| Computer software problema software problem | 9 | 2.4% | 2.1% |
| Radiofrequency interference (rfi) | 9 | 2.4% | 0.2% |
| Material twisted/bent | 8 | 2.1% | 0.2% |
| Unintended application program shut down | 8 | 2.1% | 0.2% |
| Device sensing problem | 6 | 1.6% | 0.4% |
| Activation, positioning or separation problem | 4 | 1.1% | 0.1% |
| Data problem | 2 | 0.5% | 0.5% |
| Erratic or intermittent display | 2 | 0.5% | 0.2% |
| Insufficient device problem information | 2 | 0.5% | 5.5% |
| Application program freezes or fails to launch | 1 | 0.3% | 0.4% |
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 |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 91 | 23.9% |
| Pneumothoraxa collapsed lung | 47 | 12.4% |
| Hemorrhage/blood loss/bleeding | 14 | 3.7% |
| Unintended radiation exposure | 6 | 1.6% |
| Cardiac arrestthe heart stopped | 4 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 4 | 1.1% |
| Bronchial hemorrhage | 2 | 0.5% |
| Cerebral edema | 1 | 0.3% |
| Cognitive changes | 1 | 0.3% |
| Convulsion/seizure | 1 | 0.3% |
| Dyspneashortness of breath | 1 | 0.3% |
| Encephalopathy | 1 | 0.3% |
| Fever | 1 | 0.3% |
| Fistula | 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 | Illumisite | Product code JAK | All MAUDE reports |
|---|---|---|---|
| Reports | 380 | 5,268 | 26,136,888 |
| Share of that pool | — | 7.2% | 0% |
| Classified as death, per 1,000 reports | 5 | 42 | 9 |
| Classified as injury | 42.4% | 28.9% | 36.2% |
| Classified as malfunction | 57.1% | 54.1% | 62.3% |
| Filed by the manufacturer | 97.6% | 89.7% | 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 JAK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Superdimension Inreach System | 398 | 0 | 26.6% |
| Brilliance 64 | 357 | 0 | 0.6% |
| Brilliance 16 Air | 249 | 0 | 0.4% |
| Ict | 222 | 0 | 0.5% |
| Superdimension Inreach Bronchus System | 213 | 0 | 14.1% |
| Superdimension | 227 | 5 | 7% |
| Edge | 859 | 171 | 0.1% |
| Toshiba | 158 | 0 | 1.9% |
| Acist | 348 | 14 | 10.6% |
| Philips | 190 | 0 | 6.3% |
| Artis zee biplane | 182 | 7 | 1.1% |
| Artis Zee Ceiling | 209 | 4 | 0.5% |
| Bd Vacutainer Push Button Blood Collection Set With Pre-Attached Holder | 206 | 0 | 0% |
| BD Vacutainer Safety-Lok Blood Collection Set | 819 | 144 | 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 Illumisite reports
How many FDA reports name Illumisite?
380 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 70 in the latest 12 months.
What kinds of events are reported?
malfunction (57.1%), injury (42.4%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (52.4%), application program problem (25.3%), patient data problem (13.9%), connection problem (8.7%) and failure to advance (6.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Illumisite 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.