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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §892.1710 (Radiology panel).

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FDA MAUDE casebook

openFDA event book System, X-Ray, Mammographic LIGHT-BOOK · MAUDE

#933 of 1000 · 443 reports · 1993–2026

  • BOOK 443 reports
  • RANK #933 of 1000
  • DEATH 0 death-typed
  • INJ 107 injury-typed
  • MALF 273 malfunction
  • SPAN 1993–2026
  • PEAK 1998: 53
  • PHOTO Shunt

Nearest event-volume peer: Shunt, Portosystemic, Endoprosthesis (1 report gap)

System, X-Ray, Mammographic sits #933 of 1000 among tracked device types with 443 MAUDE reports spanning 1993–2026. 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 →

Injury-coded reports sit below the device-type norm

System, X-Ray, Mammographic carries 24.2% INJURY-coded reports, 6.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 24.2% corpus 30.3% · below corpus mean (-6.1 pp)
  • MALF 61.6% corpus 64.8% · below corpus mean (-3.2 pp)

Lead product-problem code Unintended System Motion is 21% of coded problems · Lead manufacturer HOLOGIC, INC accounts for 61% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

System, X-Ray, Mammographic in the event-volume neighbourhood

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

reports

What this shows System, X-Ray, Mammographic carries 443 MAUDE reports, ranked #933 of 1000.

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

Event Types

Malfunction 273 (61.6%)
Injury 107 (24.2%)
Other 43 (9.7%)
16 (3.6%)
No answer provided 4 (0.9%)

Patient Outcomes

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

276 (60.8%)
Other 136 (30.0%)
Required Intervention 19 (4.2%)
R 8 (1.8%)
Hospitalization 6 (1.3%)
Disability 4 (0.9%)
S 2 (0.4%)
O 1 (0.2%)
Invalid Data 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Unintended System Motion 69
Use of Device Problem 29
Unintended Arm Motion 21
Other (for use when an appropriate device code cannot be identified) 19
Unknown (for use when the device problem is not known) 19
Adverse Event Without Identified Device or Use Problem 17
Self-Activation or Keying 16
Signal Artifact/Noise 16
Device Remains Activated 15
Component Falling 14
Improper or Incorrect Procedure or Method 14
Imprecision 12
Break 9
Device Operates Differently Than Expected 9
Positioning Problem 9
Design/structure problem 8
Poor Quality Image 8
Device Operational Issue 7
Nonstandard Device 7
Sticking 7

Yearly Trend

93
1993: 2
94
1994: 5
95
1995: 5
96
1996: 10
97
1997: 17
98
1998: 53
99
1999: 26
00
2000: 13
01
2001: 13
02
2002: 12
03
2003: 11
04
2004: 7
05
2005: 17
06
2006: 14
07
2007: 11
08
2008: 5
09
2009: 14
10
2010: 7
11
2011: 5
12
2012: 18
13
2013: 9
14
2014: 7
15
2015: 8
16
2016: 9
17
2017: 12
18
2018: 25
19
2019: 39
20
2020: 7
21
2021: 9
22
2022: 4
23
2023: 8
24
2024: 5
25
2025: 15
26
2026: 21

Reports rose to 15 in 2025, up from an average of 7 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, X-Ray, Mammographic

Top Manufacturers

HOLOGIC, INC 97
HOLOGIC, INC. 48
UNK 15

Event Locations

210 (47.4%)
I 81 (18.3%)
HOSPITAL 61 (13.8%)
NOT APPLICABLE 41 (9.3%)
NO INFORMATION 18 (4.1%)
INVALID DATA 12 (2.7%)
OUTPATIENT DIAGNOSTIC FACILITY 11 (2.5%)
UNKNOWN 8 (1.8%)
OTHER 1 (0.2%)

Compare HOLOGIC, INC vs HOLOGIC, INC. →

Nationwide devices with a comparable report-volume footprint

System, X-Ray, Mammographic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (443 here).

Shunt, Portosystemic, Endoprosthesis 444 Biliary Catheter For Stone Removal That May… 441 Shockwave Intravascular Lithotripsy System 445 Inhibitor, Peridural Fibrosis 440

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for System, X-Ray, Mammographic 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 System, X-Ray, Mammographic; 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.