Device brand name · Mammography system

Selenia Dimensions Mammography Systems, 3D: medical device reports filed with FDA

451 reports name it, 2018–2026. Manufacturer given most often on reports: Hologic. Product code OTE.

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.

451
device reports naming the brand: 0% of all MAUDE reports · about 53 a year; 114
reports, 12 months to August 2026: 58 in the 12 months before; 96.7%
classified as malfunction: 94% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

451 medical device reports received by FDA name the brand "Selenia Dimensions Mammography Systems, 3D" (mammography system); the manufacturer given most often on reports is Hologic; received from January 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

114 reports arrived in the 12 months to August 2026, up 97% from 58 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 (96.7%) and injury (3.3%); across all digital breast tomosynthesis reports (product code OTE) death is recorded in 1.2% and malfunction in 94%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are unintended system motion (74.3%), unintended movement (5.5%) and break (5.1%). The patient problems coded most often are not applicable, laceration(s) and bone fracture(s). 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

Death0%0

Injury3.3%15

Malfunction96.7%436

Other0%0

Not given0%0

Who filed the report

Manufacturer report99.8%450

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0.2%1

Grey bar: all 1,001 reports carrying product code OTE. 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	335	74.3%	53.6%
Unintended movement	25	5.5%	4.4%
Breakthe device broke	23	5.1%	2.8%
Calibration problem	6	1.3%	0.8%
Vibration	6	1.3%	1%
Mechanical problema mechanical problem	5	1.1%	0.8%
Device emits odor	4	0.9%	0.7%
Fracturea broken bone	4	0.9%	0.8%
Shielding failure	4	0.9%	0.7%
Collapse	3	0.7%	0.6%
Crackthe device cracked	3	0.7%	0.4%
Leak/splashthe device leaked	3	0.7%	0.3%
Poor quality image	3	0.7%	9.9%
Unintended electrical shock	3	0.7%	0.6%
Defective component	2	0.4%	0.5%
Device displays incorrect message	2	0.4%	6%
Flare or flash	2	0.4%	0.4%
Imprecision	2	0.4%	0.3%
Noise, audible	2	0.4%	0.6%
Application program freezes or fails to launch	1	0.2%	0.1%

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	14	3.1%
Laceration(s)	4	0.9%
Bone fracture(s)	2	0.4%
Electric shockan electric shock	2	0.4%
Abrasion	1	0.2%
Breast discomfort/pain	1	0.2%
Bruise/contusion	1	0.2%
Burn(s)a burn	1	0.2%
Discomfortdiscomfort	1	0.2%
Ecchymosis	1	0.2%
Emotional changes	1	0.2%
Headachehead pain	1	0.2%
Misdiagnosis	1	0.2%
Neck painneck pain	1	0.2%
No patient involvement	1	0.2%

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

In context

Measure	Selenia Dimensions Mammography Systems, 3D	Product code OTE	All MAUDE reports
Reports	451	1,001	26,136,888
Share of that pool	—	45.1%	0%
Classified as death, per 1,000 reports	0	12	9
Classified as injury	3.3%	4.7%	36.2%
Classified as malfunction	96.7%	94%	62.3%
Filed by the manufacturer	99.8%	96.2%	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 OTE

Brand	Reports	Latest 12 months	Classified as death
Selenia Dimensions Mammography System 3d	256	0	0%
3Dimensions	194	97	0%
Selenia Mammography System	179	0	0%
Selenia Dimensions Mammography System	165	21	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 Dimensions Mammography Systems, 3D reports

How many FDA reports name Selenia Dimensions Mammography Systems, 3D?

451 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 114 in the latest 12 months.

What kinds of events are reported?

malfunction (96.7%) and injury (3.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

unintended system motion (74.3%), unintended movement (5.5%), break (5.1%), calibration problem (1.3%) and vibration (1.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Selenia Dimensions Mammography Systems, 3D 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.