PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

System, Planning, Radiation Therapy Treatment

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 System LIGHT-BOOK · MAUDE

#730 of 1000 · 804 reports · 1998–2026

  • BOOK 804 reports
  • RANK #730 of 1000
  • DEATH 11 death-typed
  • INJ 95 injury-typed
  • MALF 623 malfunction
  • SPAN 1998–2026
  • PEAK 2010: 78
  • PHOTO Drape

Nearest event-volume peer: Drape, Surgical, Antimicrobial (1 report gap)

System, Planning, Radiation Therapy Treatment sits #730 of 1000 among tracked device types with 804 MAUDE reports spanning 1998–2026. 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 carries 11.8% INJURY-coded reports, 18.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 11.8% corpus 30.3% · below corpus mean (-18.5 pp)
  • MALF 77.5% corpus 64.8% · above corpus mean (+12.7 pp)

Lead product-problem code Computer Software Problem is 36% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 100% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

System in the event-volume neighbourhood

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

reports

What this shows System, Planning, Radiation Therapy Treatment carries 804 MAUDE reports, ranked #730 of 1000.

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

Event Types

Malfunction 623 (77.5%)
Injury 95 (11.8%)
Other 62 (7.7%)
13 (1.6%)
Death 11 (1.4%)

Patient Outcomes

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

593 (72.4%)
Other 164 (20.0%)
Death 15 (1.8%)
Hospitalization 11 (1.3%)
Required Intervention 10 (1.2%)
Disability 9 (1.1%)
S 5 (0.6%)
O 4 (0.5%)
H 2 (0.2%)
L 2 (0.2%)
R 2 (0.2%)
Life Threatening 2 (0.2%)

Top Product Problems

Computer Software Problem 288
Application Program Problem: Dose Calculation Error 105
Device Operates Differently Than Expected 50
Use of Device Problem 49
Improper or Incorrect Procedure or Method 46
Display or Visual Feedback Problem 26
Other (for use when an appropriate device code cannot be identified) 24
Image Orientation Incorrect 23
Image Reversal 22
Data Problem 21
Adverse Event Without Identified Device or Use Problem 20
Incorrect Software Programming Calculations 19
Application Program Problem 15
Insufficient Device Problem Information 15
Improper Device Output 14
Radiation overexposure 14
Use of Incorrect Control/Treatment Settings 14
Installation error 13
Application Program Problem: Parameter Calculation Error 12
Loss of Data 12

Yearly Trend

98
1998: 5
99
1999: 16
00
2000: 8
01
2001: 14
02
2002: 38
03
2003: 19
04
2004: 24
05
2005: 8
06
2006: 16
07
2007: 24
08
2008: 51
09
2009: 24
10
2010: 78
11
2011: 73
12
2012: 39
13
2013: 33
14
2014: 35
15
2015: 30
16
2016: 27
17
2017: 16
18
2018: 25
19
2019: 25
20
2020: 26
21
2021: 15
22
2022: 22
23
2023: 76
24
2024: 9
25
2025: 21
26
2026: 7

Reports fell to 21 in 2025, down from an average of 43 in the two years before.

Related Entities for System, Planning, Radiation Therapy Treatment

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 31

Event Locations

587 (73.0%)
I 101 (12.6%)
HOSPITAL 53 (6.6%)
OTHER 25 (3.1%)
NO INFORMATION 19 (2.4%)
NOT APPLICABLE 10 (1.2%)
OUTPATIENT TREATMENT FACILITY 5 (0.6%)
UNKNOWN 3 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System: 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 (804 here).

Drape, Surgical, Antimicrobial 803 Intracranial Coil-Assist Stent 806 Cannula, Ophthalmic 807 Humidifier, Non-Direct Patient Interface 801

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Cabinet, Table And Tray, Anesthesia 11 Circuit, Breathing 11 Collector 11 Condenser, Heat And Moisture 11

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

Disclaimer: MAUDE figures for System 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; 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.