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2026 data FDA MAUDE openFDA FDA Class II

System, X-Ray, Tomography, Computed

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 §892.1750 (Radiology panel).

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FDA MAUDE casebook

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

#307 of 1000 · 5,243 reports · 1993–2026

  • BOOK 5,243 reports
  • RANK #307 of 1000
  • DEATH 219 death-typed
  • INJ 1,515 injury-typed
  • MALF 2,835 malfunction
  • SPAN 1993–2026
  • PEAK 2018: 543
  • PHOTO Sterilizer, Chemical

Nearest event-volume peer: Sterilizer, Chemical (1 report gap)

System, X-Ray, Tomography, Computed sits #307 of 1000 among tracked device types with 5,243 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 → · Similar-volume device →

Malfunction reports sit below the device-type norm

System, X-Ray, Tomography, Computed carries 54.1% MALFUNCTION-coded reports, 10.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.2% corpus 1.5% · above corpus mean (+2.7 pp)
  • INJ 28.9% corpus 30.3% · below corpus mean (-1.4 pp)
  • MALF 54.1% corpus 64.8% · below corpus mean (-10.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Top event location is 52% of location-tagged rows .

System, X-Ray, Tomography, Computed in the event-volume neighbourhood

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

reports

What this shows System, X-Ray, Tomography, Computed carries 5,243 MAUDE reports, ranked #307 of 1000.

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

Event Types

Malfunction 2,835 (54.1%)
Injury 1,515 (28.9%)
480 (9.2%)
Death 219 (4.2%)
Other 111 (2.1%)
No answer provided 83 (1.6%)

Patient Outcomes

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

3,381 (59.3%)
Other 929 (16.3%)
Hospitalization 358 (6.3%)
Required Intervention 303 (5.3%)
R 224 (3.9%)
Death 219 (3.8%)
O 154 (2.7%)
H 42 (0.7%)
Life Threatening 30 (0.5%)
L 23 (0.4%)
Disability 15 (0.3%)
S 14 (0.2%)
D 6 (0.1%)
Congenital Anomaly 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 680
Signal Artifact/Noise 486
Device Operates Differently Than Expected 467
Device Displays Incorrect Message 325
Degraded 297
Insufficient Device Problem Information 288
Application Program Problem 201
Mechanical Problem 191
Use of Device Problem 164
Unintended System Motion 158
Improper or Incorrect Procedure or Method 155
Unknown (for use when the device problem is not known) 143
Unintended Movement 138
Patient Data Problem 126
Break 116
Computer Software Problem 115
Image Display Error/Artifact 105
Sticking 96
Device Operational Issue 91
Display or Visual Feedback Problem 88

Yearly Trend

93
1993: 5
94
1994: 5
95
1995: 4
96
1996: 13
97
1997: 15
98
1998: 19
99
1999: 7
00
2000: 25
01
2001: 16
02
2002: 41
03
2003: 35
04
2004: 33
05
2005: 26
06
2006: 19
07
2007: 76
08
2008: 120
09
2009: 105
10
2010: 119
11
2011: 205
12
2012: 192
13
2013: 414
14
2014: 308
15
2015: 454
16
2016: 365
17
2017: 338
18
2018: 543
19
2019: 233
20
2020: 177
21
2021: 261
22
2022: 200
23
2023: 310
24
2024: 212
25
2025: 222
26
2026: 126

Reports in 2025 (222) held close to the prior two-year average of 261.

Related Entities for System, X-Ray, Tomography, Computed

Event Locations

2,720 (51.9%)
I 1,879 (35.8%)
HOSPITAL 426 (8.1%)
NO INFORMATION 151 (2.9%)
OUTPATIENT DIAGNOSTIC FACILITY 26 (0.5%)
INVALID DATA 16 (0.3%)
OUTPATIENT TREATMENT FACILITY 9 (0.2%)
UNKNOWN 8 (0.2%)
OTHER 6 (0.1%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, X-Ray, Tomography, Computed: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,243 here).

Sterilizer, Chemical 5,242 Expander, Surgical, Skin Graft 5,240 Dilator, Esophageal 5,224 Light, Surgical, Ceiling Mounted 5,203

Similar death-typed counts

Nearest other device types by death-typed report count (219 here), distinct from the volume row.

Catheter 218 Restraint, Protective 221 Shunt, Central Nervous System And Components 222 Patch 215

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

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