Devices › Interventional fluoroscopic x-ray system
Device brand name · Interventional fluoroscopic x-ray system
O-Arm O2 Imaging System: medical device reports filed with FDA
10,979 reports name it, 2015–2026. Manufacturer given most often on reports: Medtronic Navigation Littleton. Product code OWB.
- 10,979
- device reports naming the brand
- 0% of all MAUDE reports · about 991 a year
- 681
- reports, 12 months to August 2026
- 1,785 in the 12 months before
- 99%
- classified as malfunction
- 98.5% across the product code
- 0.1%
- classified as death, as reported
- 6 reports · not verified by FDA
10,979 medical device reports received by FDA name the brand "O-Arm O2 Imaging System" (interventional fluoroscopic x-ray system); the manufacturer given most often on reports is Medtronic Navigation Littleton; received from June 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
681 reports arrived in the 12 months to August 2026, down 62% from 1,785 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%), injury (0.9%) and death (0.1%); across all interventional fluoroscopic x-ray system reports (product code OWB) death is recorded in 0.2% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are application program freezes or fails to launch (33.3%), device operates differently than expected (10.2%) and positioning problem (9.3%). The patient problems coded most often are no patient involvement, unintended radiation exposure and radiation exposure, unintended. 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 50,356 reports carrying product code OWB. 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 freezes or fails to launch | 3,660 | 33.3% | 8.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,119 | 10.2% | 2.5% |
| Positioning problem | 1,016 | 9.3% | 2.4% |
| Radiation output failure | 1,010 | 9.2% | 21% |
| Failure to advance | 960 | 8.7% | 1.9% |
| Noise, audible | 676 | 6.2% | 1.6% |
| Communication or transmission problemthe device could not communicate or transmit | 666 | 6.1% | 1.7% |
| Device sensing problem | 585 | 5.3% | 1.3% |
| Poor quality image | 482 | 4.4% | 1.2% |
| Application program problem | 470 | 4.3% | 0.9% |
| Electrical /electronic property probleman electrical or electronic problem | 468 | 4.3% | 1.1% |
| Mechanical problema mechanical problem | 400 | 3.6% | 1% |
| Device displays incorrect message | 313 | 2.9% | 3.4% |
| Unexpected shutdown | 266 | 2.4% | 0.7% |
| Incorrect, inadequate or imprecise result or readings | 256 | 2.3% | 0.5% |
| Image display error/artifact | 247 | 2.2% | 0.7% |
| Material deformation | 229 | 2.1% | 0.5% |
| Imprecision | 213 | 1.9% | 0.5% |
| Failure to power up | 211 | 1.9% | 1.9% |
| Calibration problem | 203 | 1.8% | 0.5% |
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 | 2,139 | 19.5% |
| Unintended radiation exposure | 17 | 0.2% |
| Radiation exposure, unintended | 12 | 0.1% |
| Iatrogenic source | 9 | 0.1% |
| Painpain, site not specified | 8 | 0.1% |
| Tissue damage | 8 | 0.1% |
| Spinal column injury | 6 | 0.1% |
| Bone fracture(s) | 4 | 0% |
| Post operative wound infection | 4 | 0% |
| Nerve damage | 3 | 0% |
| Convulsion/seizure | 2 | 0% |
| Dysphasia | 2 | 0% |
| Full thickness (third degree) burn | 2 | 0% |
| Headachehead pain | 2 | 0% |
| Injurya physical injury | 2 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | O-Arm O2 Imaging System | Product code OWB | All MAUDE reports |
|---|---|---|---|
| Reports | 10,979 | 50,356 | 26,136,888 |
| Share of that pool | — | 21.8% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 0.9% | 1.2% | 36.2% |
| Classified as malfunction | 99% | 98.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 OWB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Allura Xper FD | 20,061 | 5,580 | 0.1% |
| Azurion | 10,988 | 3,673 | 0.1% |
| Allura Xper FD20 | 2,179 | 676 | 0.6% |
| Allura Xper FD20/10 & Allura Xper FD20/20 | 400 | 130 | 0.3% |
| O2 | 352 | 0 | 0.3% |
| Base Sys Bi70002000 O-Arm Sys O2 | 336 | 0 | 0% |
| Artis zee floor | 232 | 6 | 3.4% |
| Artis Zee Ceiling | 209 | 4 | 0.5% |
| O2 O-Arm Imaging System | 154 | 0 | 0% |
| O-Arm | 386 | 0 | 0% |
| Artis zee biplane | 182 | 7 | 1.1% |
| Allura Xper FD10/10 | 327 | 111 | 0.3% |
| O-Arm Imaging System | 396 | 44 | 1.5% |
| Allura Xper FD10 | 1,328 | 404 | 1.3% |
| Innova | 868 | 32 | 0.7% |
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." 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 O-Arm O2 Imaging System reports
How many FDA reports name O-Arm O2 Imaging System?
10,979 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 681 in the latest 12 months.
What kinds of events are reported?
malfunction (99%), injury (0.9%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
application program freezes or fails to launch (33.3%), device operates differently than expected (10.2%), positioning problem (9.3%), radiation output failure (9.2%) and failure to advance (8.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that O-Arm O2 Imaging System 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.