Devices › System, x-ray, fluoroscopic, image-intensified
Device brand name · Fluoroscopic x-ray
Ge Oec 9900 Elite: medical device reports filed with FDA
191 reports name it, 2006–2008. Manufacturer given most often on reports: Ge Oec Medical Systems. Product code JAA.
- 191
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99%
- classified as malfunction
- 99.5% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
191 medical device reports received by FDA name the brand "Ge Oec 9900 Elite" (fluoroscopic x-ray); the manufacturer given most often on reports is Ge Oec Medical Systems; received from November 2006 to July 2008. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (99%), death (0.5%) and other (0.5%); across all system, x-ray, fluoroscopic, image-intensified reports (product code JAA) death is recorded in 0% and malfunction in 99.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device issue (21.5%), computer failure (18.8%) and sticking (14.1%). The patient problems coded most often are no patient involvement, death and not applicable. 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 Ge Oec 9900 Elite was received in the five years to August 2026; the latest was received in July 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 90,607 reports carrying product code JAA. 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 issuea problem with the device | 41 | 21.5% | 2.6% |
| Computer failure | 36 | 18.8% | 3.3% |
| Sticking | 27 | 14.1% | 3.3% |
| Device displays incorrect message | 26 | 13.6% | 24.6% |
| Repair | 9 | 4.7% | 1.5% |
| Computer hardware error | 8 | 4.2% | 0.7% |
| Image resolution poor | 7 | 3.7% | 2% |
| Arcing | 6 | 3.1% | 0.8% |
| Loss of powerthe device lost power | 6 | 3.1% | 3.4% |
| Failure, intermittent | 5 | 2.6% | 1.5% |
| Poor quality image | 5 | 2.6% | 4.1% |
| Self-activation or keying | 5 | 2.6% | 1.5% |
| Image display error/artifact | 4 | 2.1% | 1.4% |
| Overheating of device | 4 | 2.1% | 0.2% |
| System fails to activate | 4 | 2.1% | 0.5% |
| Failure to power up | 3 | 1.6% | 3.9% |
| No display/image | 3 | 1.6% | 10.7% |
| Noise | 3 | 1.6% | 0.7% |
| Unintended system motionthe device moved when it should not have | 3 | 1.6% | 0.5% |
| Device, removal of (non-implant) | 2 | 1% | 0% |
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 | 3 | 1.6% |
| Deaththe patient died; cause not stated by this term | 1 | 0.5% |
| Not applicable | 1 | 0.5% |
| Therapy/non-surgical treatment/delayed/prolonged | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ge Oec 9900 Elite | Product code JAA | All MAUDE reports |
|---|---|---|---|
| Reports | 191 | 90,607 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 5 | 0 | 9 |
| Classified as injury | 0% | 0.2% | 36.2% |
| Classified as malfunction | 99% | 99.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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 JAA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ge Oec 9800 | 8,527 | 0 | 0% |
| Ge Oec 9900 | 3,253 | 0 | 0% |
| Ge Oec 9600 | 2,046 | 0 | 0% |
| Stenoscop | 1,871 | 0 | 0% |
| Ge Oec 2800 | 750 | 0 | 0% |
| Ge Oec 6800 | 750 | 0 | 0% |
| Stenoscope | 692 | 0 | 0% |
| Ge Oec 2600 | 545 | 0 | 0% |
| Ge Oec 8800 | 405 | 0 | 0% |
| Oec 9800 | 330 | 0 | 0% |
| Fluorostar | 304 | 0 | 0% |
| C-Arm | 275 | 4 | 0% |
| Ge Oec 6600 | 273 | 0 | 0% |
| Oec 9900 | 187 | 0 | 0% |
| Entrak 2500 | 247 | 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 Ge Oec 9900 Elite reports
How many FDA reports name Ge Oec 9900 Elite?
191 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 (99%), death (0.5%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device issue (21.5%), computer failure (18.8%), sticking (14.1%), device displays incorrect message (13.6%) and repair (4.7%). 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 Ge Oec 9900 Elite 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.