Devices › System, x-ray, tomography, computed
Device brand name · Computed tomography x-ray
Brilliance 64: medical device reports filed with FDA
357 reports name it, 2009–2018. Manufacturer given most often on reports: Philips Medical Systems Cleveland. Product code JAK.
- 357
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 58%
- classified as malfunction
- 54.1% across the product code
- 0.6%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 357 reports that name the brand "Brilliance 64" (computed tomography x-ray), received between July 2009 and May 2018; the manufacturer given most often on reports is Philips Medical Systems Cleveland. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (58%), injury (2.8%) and other (1.1%); 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 signal artifact/noise (23.8%), device operates differently than expected (23.2%) and degraded (12.6%). The patient problems coded most often are no patient involvement, misdiagnosis and electric shock. 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
No report naming Brilliance 64 was received in the five years to August 2026; the latest was received in May 2018.
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 |
|---|---|---|---|
| Signal artifact/noise | 85 | 23.8% | 9.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 83 | 23.2% | 8.9% |
| Degraded | 45 | 12.6% | 5.6% |
| Mechanical problema mechanical problem | 42 | 11.8% | 3.5% |
| Sticking | 29 | 8.1% | 1.8% |
| Unintended movement | 29 | 8.1% | 2.5% |
| Unintended system motionthe device moved when it should not have | 20 | 5.6% | 2.9% |
| Detachment of device or device componentpart of the device came off | 13 | 3.6% | 1.2% |
| Loose or intermittent connection | 12 | 3.4% | 0.8% |
| Detachment of device component | 10 | 2.8% | 1.5% |
| Device displays incorrect message | 9 | 2.5% | 6.3% |
| Smoking | 9 | 2.5% | 0.9% |
| Calibration problem | 7 | 2% | 0.5% |
| Breakthe device broke | 6 | 1.7% | 2.2% |
| Component falling | 6 | 1.7% | 0.9% |
| Device slipped | 6 | 1.7% | 0.4% |
| Application network problem | 5 | 1.4% | 0.9% |
| Communication or transmission problemthe device could not communicate or transmit | 5 | 1.4% | 1.3% |
| Computer software problema software problem | 5 | 1.4% | 2.1% |
| Image display error/artifact | 5 | 1.4% | 1.9% |
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 |
|---|---|---|
| No patient involvement | 20 | 5.6% |
| Misdiagnosis | 4 | 1.1% |
| Electric shockan electric shock | 2 | 0.6% |
| Head injurya head injury | 2 | 0.6% |
| Injurya physical injury | 2 | 0.6% |
| Swellingswelling | 2 | 0.6% |
| Blurred vision | 1 | 0.3% |
| Bruise/contusion | 1 | 0.3% |
| Cardiac arrestthe heart stopped | 1 | 0.3% |
| Deaththe patient died; cause not stated by this term | 1 | 0.3% |
| Discomfortdiscomfort | 1 | 0.3% |
| Extravasation | 1 | 0.3% |
| Hemorrhage/blood loss/bleeding | 1 | 0.3% |
| Infiltration into tissue | 1 | 0.3% |
| Laceration(s) | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Brilliance 64 | Product code JAK | All MAUDE reports |
|---|---|---|---|
| Reports | 357 | 5,268 | 26,136,888 |
| Share of that pool | — | 6.8% | 0% |
| Classified as death, per 1,000 reports | 6 | 42 | 9 |
| Classified as injury | 2.8% | 28.9% | 36.2% |
| Classified as malfunction | 58% | 54.1% | 62.3% |
| Filed by the manufacturer | 99.4% | 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 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 Brilliance 64 reports
How many FDA reports name Brilliance 64?
357 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (58%), injury (2.8%) and other (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
signal artifact/noise (23.8%), device operates differently than expected (23.2%), degraded (12.6%), mechanical problem (11.8%) and sticking (8.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Brilliance 64 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.