Devices › System, x-ray, tomography, computed
Device brand name · System x-ray tomography computed
Superdimension: medical device reports filed with FDA
227 reports name it, 2017–2025. Manufacturer given most often on reports: Covidien - Superdimension. Product code JAK.
- 227
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 5
- reports, 12 months to August 2026
- 14 in the 12 months before
- 12.3%
- classified as malfunction
- 54.1% across the product code
- 7%
- classified as death, as reported
- 16 reports · not verified by FDA
227 medical device reports received by FDA name the brand "Superdimension" (system x-ray tomography computed); the manufacturer given most often on reports is Covidien - Superdimension; received from February 2017 to October 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
5 reports arrived in the 12 months to August 2026, down 64% from 14 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 injury (80.6%), malfunction (12.3%) and death (7%); 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 application program problem (23.3%), device displays incorrect message (13.2%) and patient data problem (13.2%). The patient problems coded most often are pneumothorax, appropriate clinical signs, symptoms and conditions term/code not available and death. 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 |
|---|---|---|---|
| Application program problem | 53 | 23.3% | 3.8% |
| Device displays incorrect message | 30 | 13.2% | 6.3% |
| Patient data problem | 30 | 13.2% | 2.4% |
| Application network problem | 16 | 7% | 0.9% |
| Communication or transmission problemthe device could not communicate or transmit | 9 | 4% | 1.3% |
| Defective devicethe device was defective | 8 | 3.5% | 0.4% |
| Connection problema connection problem | 7 | 3.1% | 1.3% |
| Programming issue | 7 | 3.1% | 0.3% |
| Failure to power up | 5 | 2.2% | 0.3% |
| Breakthe device broke | 4 | 1.8% | 2.2% |
| Display or visual feedback problem | 4 | 1.8% | 1.7% |
| Computer software problema software problem | 3 | 1.3% | 2.1% |
| Data problem | 3 | 1.3% | 0.5% |
| Device sensing problem | 3 | 1.3% | 0.4% |
| Poor quality image | 3 | 1.3% | 0.7% |
| Program or algorithm execution problem | 3 | 1.3% | 0.1% |
| Radiofrequency interference (rfi) | 3 | 1.3% | 0.2% |
| Application program freezes or fails to launch | 2 | 0.9% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.9% | 8.9% |
| Migration or expulsion of device | 2 | 0.9% | 0.1% |
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 |
|---|---|---|
| Pneumothoraxa collapsed lung | 79 | 34.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 31 | 13.7% |
| Deaththe patient died; cause not stated by this term | 16 | 7% |
| Hemorrhage/blood loss/bleeding | 16 | 7% |
| Blood loss | 9 | 4% |
| Chest painchest pain | 4 | 1.8% |
| Fever | 4 | 1.8% |
| Respiratory failurethe lungs could not supply enough oxygen | 4 | 1.8% |
| Unintended radiation exposure | 3 | 1.3% |
| Cardiac arrestthe heart stopped | 2 | 0.9% |
| Hemoptysis | 2 | 0.9% |
| Bradycardiaslow heart rate | 1 | 0.4% |
| Chronic obstructive pulmonary disease (COPD) | 1 | 0.4% |
| Dyspneashortness of breath | 1 | 0.4% |
| Fistula | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Superdimension | Product code JAK | All MAUDE reports |
|---|---|---|---|
| Reports | 227 | 5,268 | 26,136,888 |
| Share of that pool | — | 4.3% | 0% |
| Classified as death, per 1,000 reports | 70 | 42 | 9 |
| Classified as injury | 80.6% | 28.9% | 36.2% |
| Classified as malfunction | 12.3% | 54.1% | 62.3% |
| Filed by the manufacturer | 98.7% | 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% |
| Illumisite | 380 | 70 | 0.5% |
| 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% |
| 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 Superdimension reports
How many FDA reports name Superdimension?
227 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
injury (80.6%), malfunction (12.3%) and death (7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
application program problem (23.3%), device displays incorrect message (13.2%), patient data problem (13.2%), application network problem (7%) and communication or transmission problem (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Superdimension 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.