Devices › Image-intensified fluoroscopic x-ray system, mobile
Device brand name · Image-intensified fluoroscopic x-ray system m
O-Arm Imaging System: medical device reports filed with FDA
396 reports name it, 2018–2026. Manufacturer given most often on reports: Medtronic Navigation Littleton. Product code OXO.
- 396
- device reports naming the brand
- 0% of all MAUDE reports · about 51 a year
- 44
- reports, 12 months to August 2026
- 40 in the 12 months before
- 63.9%
- classified as malfunction
- 97.2% across the product code
- 1.5%
- classified as death, as reported
- 6 reports · not verified by FDA
396 medical device reports received by FDA name the brand "O-Arm Imaging System" (image-intensified fluoroscopic x-ray system m); the manufacturer given most often on reports is Medtronic Navigation Littleton; received from October 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
44 reports arrived in the 12 months to August 2026, up 10% from 40 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 (63.9%), injury (34.6%) and death (1.5%); across all image-intensified fluoroscopic x-ray system, mobile reports (product code OXO) death is recorded in 0.1% and malfunction in 97.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (16.7%), application program freezes or fails to launch (15.7%) and imprecision (14.6%). The patient problems coded most often are no patient involvement, hemorrhage/blood loss/bleeding and pain. 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 10,994 reports carrying product code OXO. 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 |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 66 | 16.7% | 0.7% |
| Application program freezes or fails to launch | 62 | 15.7% | 16.1% |
| Imprecision | 58 | 14.6% | 2.1% |
| Communication or transmission problemthe device could not communicate or transmit | 23 | 5.8% | 9.9% |
| Poor quality image | 20 | 5.1% | 3.7% |
| Positioning problem | 18 | 4.5% | 3.5% |
| Unexpected shutdown | 16 | 4% | 2.5% |
| Failure to power up | 10 | 2.5% | 2.2% |
| Failure to run on battery | 8 | 2% | 2.3% |
| Device sensing problem | 7 | 1.8% | 0.7% |
| Material deformation | 7 | 1.8% | 2.3% |
| Radiation output failure | 6 | 1.5% | 0.8% |
| Failure to advance | 4 | 1% | 0.5% |
| Failure to shut off | 4 | 1% | 0% |
| Noise, audible | 4 | 1% | 1.8% |
| Application program problem | 3 | 0.8% | 0.8% |
| Data problem | 3 | 0.8% | 0.2% |
| Failure to charge | 3 | 0.8% | 1.5% |
| Image display error/artifact | 3 | 0.8% | 0.6% |
| No display/image | 3 | 0.8% | 1.5% |
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 | 71 | 17.9% |
| Hemorrhage/blood loss/bleeding | 22 | 5.6% |
| Painpain, site not specified | 19 | 4.8% |
| Hematomaa collection of blood under the skin or in tissue | 18 | 4.5% |
| Post operative wound infection | 15 | 3.8% |
| Muscle weakness/atrophy | 13 | 3.3% |
| Cerebrospinal fluid leakage | 9 | 2.3% |
| Nerve damage | 6 | 1.5% |
| Neuropathy | 6 | 1.5% |
| Urinary retentionbeing unable to empty the bladder | 6 | 1.5% |
| Dural tear | 5 | 1.3% |
| Dysphasia | 5 | 1.3% |
| Ambulation or postural difficulties | 4 | 1% |
| Bone fracture(s) | 4 | 1% |
| Cognitive changes | 4 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | O-Arm Imaging System | Product code OXO | All MAUDE reports |
|---|---|---|---|
| Reports | 396 | 10,994 | 26,136,888 |
| Share of that pool | — | 3.6% | 0% |
| Classified as death, per 1,000 reports | 15 | 1 | 9 |
| Classified as injury | 34.6% | 2.6% | 36.2% |
| Classified as malfunction | 63.9% | 97.2% | 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 OXO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| O-Arm 1000 Imaging System | 7,035 | 2 | 0% |
| O-Arm 1000 Imaging System 3rd Edition | 2,615 | 4 | 0% |
| O-Arm | 386 | 0 | 0% |
| Medtronic Navigation | 682 | 69 | 6.7% |
| O-Arm O2 Imaging System | 10,979 | 681 | 0.1% |
| C-Arm | 275 | 4 | 0% |
| Cart 9734056 S7 Staff Shrt 100-120v Intl | 904 | 4 | 0% |
| Stealthstation | 281 | 0 | 0% |
| Stenoscop | 1,871 | 0 | 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 O-Arm Imaging System reports
How many FDA reports name O-Arm Imaging System?
396 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 44 in the latest 12 months.
What kinds of events are reported?
malfunction (63.9%), injury (34.6%) and death (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (16.7%), application program freezes or fails to launch (15.7%), imprecision (14.6%), communication or transmission problem (5.8%) and poor quality image (5.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that O-Arm 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.