Devices › Image-intensified fluoroscopic x-ray system, mobile
Device brand name · Image-intensified fluoroscopic x-ray system mobile
O-Arm 1000 Imaging System 3rd Edition: medical device reports filed with FDA
2,615 reports name it, 2015–2025. Manufacturer given most often on reports: Medtronic Navigation Littleton. Product code OXO.
- 2,615
- device reports naming the brand
- 0% of all MAUDE reports · about 233 a year
- 4
- reports, 12 months to August 2026
- 73 in the 12 months before
- 99.1%
- classified as malfunction
- 97.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 2,615 reports that name the brand "O-Arm 1000 Imaging System 3rd Edition" (image-intensified fluoroscopic x-ray system mobile), received between April 2015 and November 2025; the manufacturer given most often on reports is Medtronic Navigation Littleton. Spellings of one product vary from report to report.
4 reports arrived in the 12 months to August 2026, down 95% from 73 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 (99.1%) and injury (0.9%); 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 device operates differently than expected (26.3%), application program freezes or fails to launch (23.6%) and electrical /electronic property problem (11.5%). The patient problems coded most often are no patient involvement, iatrogenic source 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 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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 687 | 26.3% | 31.6% |
| Application program freezes or fails to launch | 617 | 23.6% | 16.1% |
| Electrical /electronic property probleman electrical or electronic problem | 301 | 11.5% | 16.7% |
| Device displays incorrect message | 246 | 9.4% | 10.6% |
| Communication or transmission problemthe device could not communicate or transmit | 208 | 8% | 9.9% |
| Device inoperablethe device could not be used | 191 | 7.3% | 9.9% |
| Positioning problem | 121 | 4.6% | 3.5% |
| Unexpected shutdown | 101 | 3.9% | 2.5% |
| Poor quality image | 99 | 3.8% | 3.7% |
| Computer software problema software problem | 86 | 3.3% | 4.6% |
| Difficult to open or close | 81 | 3.1% | 3.5% |
| Mechanical problema mechanical problem | 80 | 3.1% | 3.3% |
| Failure to run on battery | 68 | 2.6% | 2.3% |
| Failure to power up | 67 | 2.6% | 2.2% |
| Noise, audible | 67 | 2.6% | 1.8% |
| Device stops intermittentlythe device stopped now and then | 61 | 2.3% | 2.3% |
| Calibration problem | 58 | 2.2% | 1.7% |
| Material deformation | 57 | 2.2% | 2.3% |
| Application interface becomes non-functional or program exits abnormally | 50 | 1.9% | 2.2% |
| Radiation output failure | 50 | 1.9% | 0.8% |
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 | 1,204 | 46% |
| Iatrogenic source | 6 | 0.2% |
| Radiation exposure, unintended | 4 | 0.2% |
| Spinal column injury | 3 | 0.1% |
| Painpain, site not specified | 2 | 0.1% |
| Tissue damage | 2 | 0.1% |
| Cerebrospinal fluid leakage | 1 | 0% |
| Cognitive changes | 1 | 0% |
| Contusiona bruise | 1 | 0% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0% |
| Injurya physical injury | 1 | 0% |
| Loss of range of motion | 1 | 0% |
| Nerve damage | 1 | 0% |
| Numbnessnumbness | 1 | 0% |
| Post operative wound infection | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | O-Arm 1000 Imaging System 3rd Edition | Product code OXO | All MAUDE reports |
|---|---|---|---|
| Reports | 2,615 | 10,994 | 26,136,888 |
| Share of that pool | — | 23.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 0.9% | 2.6% | 36.2% |
| Classified as malfunction | 99.1% | 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 Imaging System | 396 | 44 | 1.5% |
| 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 1000 Imaging System 3rd Edition reports
How many FDA reports name O-Arm 1000 Imaging System 3rd Edition?
2,615 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.
What kinds of events are reported?
malfunction (99.1%) and injury (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (26.3%), application program freezes or fails to launch (23.6%), electrical /electronic property problem (11.5%), device displays incorrect message (9.4%) and communication or transmission problem (8%). 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 1000 Imaging System 3rd Edition 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.