2026 data FDA MAUDE openFDA

Full Field Digital, System, X-Ray, Mammographic

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Full Field Digital LIGHT-BOOK · MAUDE

#794 of 1000 · 627 reports · 2008–2026

  • BOOK 627 reports
  • RANK #794 of 1000
  • DEATH 5 death-typed
  • INJ 51 injury-typed
  • MALF 458 malfunction
  • SPAN 2008–2026
  • PEAK 2018: 145
  • PHOTO Aberrometer

Nearest event-volume peer: Aberrometer, Ophthalmic (1 report gap)

Full Field Digital, System, X-Ray, Mammographic sits #794 of 1000 among tracked device types with 627 MAUDE reports spanning 2008–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 8.1% corpus 30.4% · below corpus mean (-22.3 pp)
  • MALF 73.0% corpus 64.5% · above corpus mean (+8.5 pp)

Lead product-problem code Unintended System Motion is 35% of coded problems · Lead manufacturer HOLOGIC, INC accounts for 54% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Full Field Digital in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Full Field Digital, System, X-Ray, Mammographic carries 627 MAUDE reports, ranked #794 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 458 (73.0%)
No answer provided 96 (15.3%)
Injury 51 (8.1%)
Other 16 (2.6%)
Death 5 (0.8%)
1 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

531 (84.2%)
Other 78 (12.4%)
Required Intervention 9 (1.4%)
Hospitalization 6 (1.0%)
D 4 (0.6%)
R 1 (0.2%)
Death 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Unintended System Motion 200
Device Operational Issue 112
Device Displays Incorrect Message 54
Poor Quality Image 35
Device Operates Differently Than Expected 34
Unintended Movement 27
Break 17
Use of Device Problem 17
Adverse Event Without Identified Device or Use Problem 16
Device Stops Intermittently 8
Mechanical Problem 8
Detachment of Device or Device Component 6
Improper or Incorrect Procedure or Method 6
Insufficient Information 6
Collapse 3
Detachment Of Device Component 3
Fire 3
Mechanical Jam 3
Shielding Failure 3
Unintended Collision 3

Yearly Trend

08
2008: 4
09
2009: 3
10
2010: 2
11
2011: 10
12
2012: 6
13
2013: 11
14
2014: 7
15
2015: 5
16
2016: 19
17
2017: 115
18
2018: 145
19
2019: 80
20
2020: 49
21
2021: 25
22
2022: 36
23
2023: 29
24
2024: 33
25
2025: 40
26
2026: 8

Related Entities for Full Field Digital, System, X-Ray, Mammographic

Top Manufacturers

Event Locations

I 319 (50.9%)
188 (30.0%)
NO INFORMATION 106 (16.9%)
HOSPITAL 9 (1.4%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.6%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare HOLOGIC, INC vs HOLOGIC, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Full Field Digital, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (627 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Disclaimer: MAUDE figures for Full Field Digital are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Full Field Digital; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.