Devices › Full field digital, system, x-ray, mammographic
Device brand name · Full field digital mammography system
Selenia Mammography System: medical device reports filed with FDA
179 reports name it, 2011–2022. Manufacturer given most often on reports: Hologic. Product code MUE.
- 179
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93.9%
- classified as malfunction
- 74.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 179 reports that name the brand "Selenia Mammography System" (full field digital mammography system), received between October 2011 and July 2022; the manufacturer given most often on reports is Hologic. 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 (93.9%), injury (5%) and other (1.1%); across all full field digital, system, x-ray, mammographic reports (product code MUE) death is recorded in 0.8% and malfunction in 74.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unintended system motion (27.9%), device displays incorrect message (21.2%) and device operates differently than expected (14.5%). The patient problems coded most often are not applicable and no patient involvement. 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 662 reports carrying product code MUE. 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 |
|---|---|---|---|
| Unintended system motionthe device moved when it should not have | 50 | 27.9% | 32.2% |
| Device displays incorrect message | 38 | 21.2% | 8.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 26 | 14.5% | 5.4% |
| Device operational issue | 12 | 6.7% | 16.9% |
| Poor quality image | 12 | 6.7% | 5.7% |
| Unintended movement | 11 | 6.1% | 5.7% |
| Device stops intermittentlythe device stopped now and then | 7 | 3.9% | 1.2% |
| Detachment of device or device componentpart of the device came off | 2 | 1.1% | 0.9% |
| Power problem | 2 | 1.1% | 0.3% |
| Breakthe device broke | 1 | 0.6% | 2.9% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.6% | 0.2% |
| Computer software problema software problem | 1 | 0.6% | 0.3% |
| Crackthe device cracked | 1 | 0.6% | 0.6% |
| Failure to disconnect | 1 | 0.6% | 0.2% |
| Flare or flash | 1 | 0.6% | 0.2% |
| Insufficient device problem information | 1 | 0.6% | 1.8% |
| Material disintegration | 1 | 0.6% | 0.2% |
| Mechanical problema mechanical problem | 1 | 0.6% | 1.5% |
| Noise, audible | 1 | 0.6% | 0.6% |
| Structural problem | 1 | 0.6% | 0.3% |
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 |
|---|---|---|
| Not applicable | 92 | 51.4% |
| No patient involvement | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Selenia Mammography System | Product code MUE | All MAUDE reports |
|---|---|---|---|
| Reports | 179 | 662 | 26,136,888 |
| Share of that pool | — | 27% | 0% |
| Classified as death, per 1,000 reports | 0 | 8 | 9 |
| Classified as injury | 5% | 8% | 36.2% |
| Classified as malfunction | 93.9% | 74.2% | 62.3% |
| Filed by the manufacturer | 100% | 94.1% | 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 MUE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Selenia Dimensions Mammography System | 165 | 21 | 0% |
| Selenia Dimensions Mammography System 3d | 256 | 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 Selenia Mammography System reports
How many FDA reports name Selenia Mammography System?
179 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 (93.9%), injury (5%) and other (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended system motion (27.9%), device displays incorrect message (21.2%), device operates differently than expected (14.5%), device operational issue (6.7%) and poor quality image (6.7%). 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 Selenia Mammography 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.