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2026 data FDA MAUDE openFDA FDA Class II

System, Tomography, Computed, Emission

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 §892.1200 (Radiology panel).

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FDA MAUDE casebook

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

#653 of 1000 · 1,051 reports · 1995–2026

  • BOOK 1,051 reports
  • RANK #653 of 1000
  • DEATH 8 death-typed
  • INJ 165 injury-typed
  • MALF 643 malfunction
  • SPAN 1995–2026
  • PEAK 2013: 240
  • PHOTO Drill, Bone, Powered

Nearest event-volume peer: Drill, Bone, Powered (0 report gap)

System, Tomography, Computed, Emission sits #653 of 1000 among tracked device types with 1,051 MAUDE reports spanning 1995–2026. 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, Tomography, Computed, Emission carries 15.7% INJURY-coded reports, 14.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 15.7% corpus 30.3% · below corpus mean (-14.6 pp)
  • MALF 61.2% corpus 64.8% · below corpus mean (-3.6 pp)

Lead product-problem code Nonstandard Device is 10% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. accounts for 100% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

System, Tomography, Computed, Emission in the event-volume neighbourhood

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

reports

What this shows System, Tomography, Computed, Emission carries 1,051 MAUDE reports, ranked #653 of 1000.

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

Event Types

Malfunction 643 (61.2%)
Injury 165 (15.7%)
118 (11.2%)
Other 117 (11.1%)
Death 8 (0.8%)

Patient Outcomes

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

831 (77.7%)
Other 120 (11.2%)
Required Intervention 64 (6.0%)
Hospitalization 21 (2.0%)
R 10 (0.9%)
Death 8 (0.7%)
Disability 6 (0.6%)
S 4 (0.4%)
O 3 (0.3%)
L 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Nonstandard Device 89
Unintended System Motion 81
Loose or Intermittent Connection 74
Component Falling 73
Device Operates Differently Than Expected 56
Improper or Incorrect Procedure or Method 56
Mechanical Problem 53
Break 41
Other (for use when an appropriate device code cannot be identified) 41
Use of Device Problem 40
Computer Software Problem 39
Detachment Of Device Component 33
Device Slipped 32
Misassembled During Installation 31
Structural Problem 29
Unintended Collision 28
Crack 27
Adverse Event Without Identified Device or Use Problem 26
Unintended Movement 25
Sticking 24

Yearly Trend

95
1995: 1
96
1996: 7
97
1997: 12
98
1998: 12
99
1999: 54
00
2000: 45
01
2001: 22
02
2002: 26
03
2003: 28
04
2004: 17
05
2005: 18
06
2006: 11
07
2007: 38
08
2008: 11
09
2009: 15
10
2010: 44
11
2011: 56
12
2012: 34
13
2013: 240
14
2014: 33
15
2015: 24
16
2016: 10
17
2017: 31
18
2018: 26
19
2019: 105
20
2020: 22
21
2021: 10
22
2022: 15
23
2023: 22
24
2024: 23
25
2025: 36
26
2026: 3

Reports rose to 36 in 2025, up from an average of 23 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, Tomography, Computed, Emission

Top Manufacturers

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 37

Event Locations

734 (69.8%)
I 202 (19.2%)
HOSPITAL 80 (7.6%)
NO INFORMATION 11 (1.0%)
INVALID DATA 10 (1.0%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (0.6%)
UNKNOWN 3 (0.3%)
OTHER 2 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
NOT APPLICABLE 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Tomography, Computed, Emission: 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 (1,051 here).

Drill, Bone, Powered 1,051 Prosthesis, Rib Replacement 1,052 Holder, Needle, Gastroenterologic 1,038 Cannula, Surgical, General & Plastic Surgery 1,037

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Bronchoscope Accessory 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8

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

Disclaimer: MAUDE figures for System, Tomography, Computed, Emission 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, Tomography, Computed, Emission; 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.