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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#303 of 1000 · 5,150 reports · 1993–2026

  • BOOK 5,150 reports
  • RANK #303 of 1000
  • DEATH 219 death-typed
  • INJ 1,495 injury-typed
  • MALF 2,763 malfunction
  • SPAN 1993–2026
  • PEAK 2018: 543
  • PHOTO Temporary Carotid Cat…

Nearest event-volume peer: Temporary Carotid Catheter For Embolic Capture (2 report gap)

System, X-Ray, Tomography, Computed sits #303 of 1000 among tracked device types with 5,150 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 →

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 4.3% corpus 1.5% · above corpus mean (+2.7 pp)
  • INJ 29.0% corpus 30.4% · below corpus mean (-1.4 pp)
  • MALF 53.7% corpus 64.5% · below corpus mean (-10.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 22% of coded problems · Top event location is 51% 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 5,150 MAUDE reports, ranked #303 of 1000.

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

Event Types

Malfunction 2,763 (53.7%)
Injury 1,495 (29.0%)
480 (9.3%)
Death 219 (4.3%)
Other 111 (2.2%)
No answer provided 82 (1.6%)

Patient Outcomes

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

3,311 (59.1%)
Other 919 (16.4%)
Hospitalization 354 (6.3%)
Required Intervention 295 (5.3%)
R 222 (4.0%)
Death 219 (3.9%)
O 153 (2.7%)
H 40 (0.7%)
Life Threatening 30 (0.5%)
L 19 (0.3%)
Disability 15 (0.3%)
S 14 (0.3%)
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 598
Signal Artifact/Noise 370
Degraded 295
Device Displays Incorrect Message 230
Application Program Problem 194
Device Operates Differently Than Expected 126
Patient Data Problem 106
Insufficient Information 103
Use of Device Problem 101
Device Operational Issue 89
Improper or Incorrect Procedure or Method 75
Break 73
Computer Software Problem 62
Image Display Error/Artifact 61
Connection Problem 57
Material Fragmentation 53
Display or Visual Feedback Problem 49
Sharp Edges 45
Application Network Problem 43
Communication or Transmission Problem 42

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: 33

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

Event Locations

2,630 (51.1%)
I 1,879 (36.5%)
HOSPITAL 424 (8.2%)
NO INFORMATION 150 (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 similar MAUDE profiles

Two openFDA-derived peer sets for System, X-Ray, Tomography, Computed, 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 (5,150 here).

Temporary Carotid Catheter For Embolic Capt… 5,148 Folders And Injectors, Intraocular Lens 5,129 Compressor, Air, Portable 5,114 Anesthesia Conduction Kit 5,092

Similar death-typed counts

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

Suture 220 Pump, Infusion, Pca 221 Restraint, Protective 221 Alternate Controller Enabled Insulin Infusi… 213

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.