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2026 data FDA MAUDE openFDA FDA Class II

Accelerator, Linear, Medical

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 §892.5050 (Radiology panel).

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FDA MAUDE casebook

openFDA event book Accelerator, Linear, Medical LIGHT-BOOK · MAUDE

#403 of 1000 · 3,068 reports · 1993–2026

  • BOOK 3,068 reports
  • RANK #403 of 1000
  • DEATH 20 death-typed
  • INJ 321 injury-typed
  • MALF 2,285 malfunction
  • SPAN 1993–2026
  • PEAK 2011: 280
  • PHOTO Lenses

Nearest event-volume peer: Lenses, Soft Contact, Extended Wear (5 report gap)

Accelerator, Linear, Medical sits #403 of 1000 among tracked device types with 3,068 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 →

Injury-coded reports sit below the device-type norm

Accelerator, Linear, Medical carries 10.5% INJURY-coded reports, 19.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 10.5% corpus 30.3% · below corpus mean (-19.8 pp)
  • MALF 74.5% corpus 64.8% · above corpus mean (+9.7 pp)

Lead product-problem code Computer Software Problem is 36% of coded problems · Top event location is 69% of location-tagged rows .

Accelerator, Linear, Medical in the event-volume neighbourhood

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

reports

What this shows Accelerator, Linear, Medical carries 3,068 MAUDE reports, ranked #403 of 1000.

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

Event Types

Malfunction 2,285 (74.5%)
Injury 321 (10.5%)
Other 298 (9.7%)
143 (4.7%)
Death 20 (0.7%)
No answer provided 1 (0.0%)

Patient Outcomes

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

2,403 (77.0%)
Other 508 (16.3%)
Required Intervention 58 (1.9%)
Hospitalization 50 (1.6%)
Death 22 (0.7%)
Disability 18 (0.6%)
R 15 (0.5%)
S 11 (0.4%)
Life Threatening 10 (0.3%)
L 9 (0.3%)
O 8 (0.3%)
H 6 (0.2%)
D 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Computer Software Problem 869
Device Operates Differently Than Expected 141
Unintended System Motion 129
Improper or Incorrect Procedure or Method 118
Use of Device Problem 117
Application Program Problem: Dose Calculation Error 111
Other (for use when an appropriate device code cannot be identified) 103
Device Displays Incorrect Message 93
Component Falling 92
Display or Visual Feedback Problem 89
Detachment Of Device Component 83
Adverse Event Without Identified Device or Use Problem 68
Break 64
Unintended Movement 60
Insufficient Device Problem Information 54
Incorrect Measurement 52
Positioning Problem 49
Malposition of Device 48
Application Program Problem: Parameter Calculation Error 47
Unintended Collision 46

Yearly Trend

93
1993: 7
94
1994: 40
95
1995: 19
96
1996: 21
97
1997: 33
98
1998: 17
99
1999: 148
00
2000: 121
01
2001: 29
02
2002: 30
03
2003: 42
04
2004: 38
05
2005: 36
06
2006: 132
07
2007: 155
08
2008: 114
09
2009: 174
10
2010: 246
11
2011: 280
12
2012: 128
13
2013: 96
14
2014: 124
15
2015: 100
16
2016: 97
17
2017: 125
18
2018: 85
19
2019: 91
20
2020: 74
21
2021: 68
22
2022: 66
23
2023: 128
24
2024: 81
25
2025: 101
26
2026: 22

Reports in 2025 (101) held close to the prior two-year average of 105.

Related Entities for Accelerator, Linear, Medical

Event Locations

2,131 (69.5%)
I 486 (15.8%)
HOSPITAL 293 (9.6%)
OUTPATIENT TREATMENT FACILITY 59 (1.9%)
INVALID DATA 24 (0.8%)
NO INFORMATION 24 (0.8%)
OTHER 22 (0.7%)
OUTPATIENT DIAGNOSTIC FACILITY 11 (0.4%)
UNKNOWN 11 (0.4%)
NOT APPLICABLE 3 (0.1%)
HOME 2 (0.1%)
NURSING HOME 1 (0.0%)
RADIOLOGY DEPARTMENT 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Accelerator, Linear, Medical: 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 (3,068 here).

Lenses, Soft Contact, Extended Wear 3,063 Agent, Injectable, Embolic 3,062 Prosthesis, Elbow, Constrained, Cemented 3,057 Test, Hepatitis B 3,089

Similar death-typed counts

Nearest other device types by death-typed report count (20 here), distinct from the volume row.

Set, I.V. Fluid Transfer 20 System 20 Transducer, Pressure, Catheter Tip 20 Apparatus 21

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

Disclaimer: MAUDE figures for Accelerator, Linear, Medical 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 Accelerator, Linear, Medical; 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.