Devices › System, x-ray, fluoroscopic, image-intensified
Device brand name · Fluoroscopic x-ray
Ge Oec 8800: medical device reports filed with FDA
405 reports name it, 2006–2010. Manufacturer given most often on reports: Ge Oec Medical Systems. Product code JAA.
- 405
- 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
- 100%
- classified as malfunction
- 99.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
405 medical device reports received by FDA name the brand "Ge Oec 8800" (fluoroscopic x-ray); the manufacturer given most often on reports is Ge Oec Medical Systems; received from November 2006 to February 2010. 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 (100%); 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 sticking (20.5%), device displays incorrect message (17.8%) and computer failure (12.6%). The patient problems coded most often are no patient involvement, surgical procedure aborted/stopped and therapy/non-surgical treatment, aborted/stopped. 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 8800 was received in the five years to August 2026; the latest was received in February 2010.
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 |
|---|---|---|---|
| Sticking | 83 | 20.5% | 3.3% |
| Device displays incorrect message | 72 | 17.8% | 24.6% |
| Computer failure | 51 | 12.6% | 3.3% |
| Device issuea problem with the device | 29 | 7.2% | 2.6% |
| Failure, intermittent | 24 | 5.9% | 1.5% |
| No display/image | 21 | 5.2% | 10.7% |
| Repair | 17 | 4.2% | 1.5% |
| Computer operating system problem | 15 | 3.7% | 17.3% |
| Poor quality image | 12 | 3% | 4.1% |
| No device output | 11 | 2.7% | 7.4% |
| Device inoperablethe device could not be used | 9 | 2.2% | 5% |
| Failure to power up | 9 | 2.2% | 3.9% |
| Image display error/artifact | 9 | 2.2% | 1.4% |
| Image resolution poor | 8 | 2% | 2% |
| Self-activation or keying | 8 | 2% | 1.5% |
| Computer hardware error | 7 | 1.7% | 0.7% |
| Loss of powerthe device lost power | 7 | 1.7% | 3.4% |
| Monitor failure | 7 | 1.7% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 1.5% | 5.8% |
| Breakthe device broke | 5 | 1.2% | 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 | 7 | 1.7% |
| Surgical procedure aborted/stopped | 1 | 0.2% |
| Therapy/non-surgical treatment, aborted/stopped | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ge Oec 8800 | Product code JAA | All MAUDE reports |
|---|---|---|---|
| Reports | 405 | 90,607 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0.2% | 36.2% |
| Classified as malfunction | 100% | 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% |
| Oec 9800 | 330 | 0 | 0% |
| Fluorostar | 304 | 0 | 0% |
| C-Arm | 275 | 4 | 0% |
| Ge Oec 6600 | 273 | 0 | 0% |
| Ge Oec 9900 Elite | 191 | 0 | 0.5% |
| 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 8800 reports
How many FDA reports name Ge Oec 8800?
405 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
sticking (20.5%), device displays incorrect message (17.8%), computer failure (12.6%), device issue (7.2%) and failure, intermittent (5.9%). 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 8800 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.