Devices › System, x-ray, fluoroscopic, image-intensified

Device brand name · Fluoroscopic x-ray

Stenoscop: medical device reports filed with FDA

1,871 reports name it, 2007–2014. Manufacturer given most often on reports: Ge Oec Medical Systems Slc. Product code JAA.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,871
device reports naming the brand: 0% of all MAUDE reports · about 98 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

FDA's MAUDE database holds 1,871 reports that name the brand "Stenoscop" (fluoroscopic x-ray), received between June 2007 and April 2014; the manufacturer given most often on reports is Ge Oec Medical Systems Slc. Spellings of one product vary from report to report.

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 computer operating system problem (21.9%), no display/image (21.6%) and no device output (18.9%). The patient problems coded most often are no patient involvement and radiation overdose. 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 Stenoscop was received in the five years to August 2026; the latest was received in April 2014.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%1,871

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%1,871

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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
Computer operating system problem	409	21.9%	17.3%
No display/image	404	21.6%	10.7%
No device output	354	18.9%	7.4%
Device operates differently than expectedthe device behaved unexpectedly	152	8.1%	5.8%
Device inoperablethe device could not be used	129	6.9%	5%
Failure to power up	82	4.4%	3.9%
Poor quality image	80	4.3%	4.1%
Loss of powerthe device lost power	76	4.1%	3.4%
Application interface becomes non-functional or program exits abnormally	60	3.2%	4.5%
Device displays incorrect message	59	3.2%	24.6%
Device stops intermittentlythe device stopped now and then	40	2.1%	1.8%
Breakthe device broke	38	2%	0.8%
Failure to back-up	30	1.6%	1.5%
Sticking	22	1.2%	3.3%
Self-activation or keying	21	1.1%	1.5%
Image display error/artifact	17	0.9%	1.4%
Loss of data	14	0.7%	1%
Improper device output	10	0.5%	0.2%
Smoking	10	0.5%	0.1%
Device emits odor	7	0.4%	0.2%

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	4	0.2%
Radiation overdose	1	0.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Stenoscop	Product code JAA	All MAUDE reports
Reports	1,871	90,607	26,136,888
Share of that pool	—	2.1%	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%
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%
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 Stenoscop reports

How many FDA reports name Stenoscop?

1,871 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?

computer operating system problem (21.9%), no display/image (21.6%), no device output (18.9%), device operates differently than expected (8.1%) and device inoperable (6.9%). 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 Stenoscop 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.