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2026 data FDA MAUDE openFDA FDA Class II

System, X-Ray, Angiographic

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 §892.1600 (Radiology panel).

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FDA MAUDE casebook

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

#255 of 1000 · 7,625 reports · 1994–2026

  • BOOK 7,625 reports
  • RANK #255 of 1000
  • DEATH 85 death-typed
  • INJ 264 injury-typed
  • MALF 7,185 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 2,204
  • PHOTO Glucose Oxidase

Nearest event-volume peer: Glucose Oxidase, Glucose (21 report gap)

System, X-Ray, Angiographic sits #255 of 1000 among tracked device types with 7,625 MAUDE reports spanning 1994–2026. 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 →

Malfunction reports run above the device-type norm

System, X-Ray, Angiographic carries 94.2% MALFUNCTION-coded reports, 29.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 3.5% corpus 30.3% · below corpus mean (-26.8 pp)
  • MALF 94.2% corpus 64.8% · above corpus mean (+29.4 pp)

Lead product-problem code Activation Failure is 34% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. accounts for 85% of manufacturer-tagged reports · Top event location is 93% of location-tagged rows .

System, X-Ray, Angiographic in the event-volume neighbourhood

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

reports

What this shows System, X-Ray, Angiographic carries 7,625 MAUDE reports, ranked #255 of 1000.

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

Event Types

Malfunction 7,185 (94.2%)
Injury 264 (3.5%)
Death 85 (1.1%)
Other 65 (0.9%)
18 (0.2%)
No answer provided 8 (0.1%)

Patient Outcomes

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

6,921 (92.8%)
Other 281 (3.8%)
Death 86 (1.2%)
Required Intervention 74 (1.0%)
Life Threatening 25 (0.3%)
Hospitalization 24 (0.3%)
R 16 (0.2%)
O 11 (0.1%)
S 6 (0.1%)
L 4 (0.1%)
D 2 (0.0%)
H 2 (0.0%)
Disability 2 (0.0%)

Top Product Problems

Activation Failure 2,449
Radiation Output Failure 1,917
Positioning Failure 768
No Display/Image 505
Device Operates Differently Than Expected 262
No Device Output 166
Device Displays Incorrect Message 145
Loss of Power 121
Device Inoperable 107
Unintended System Motion 104
Failure to Power Up 96
Insufficient Device Problem Information 92
Component Falling 84
Self-Activation or Keying 64
Device Issue 57
Application Interface Becomes Non-Functional Or Program Exits Abnormally 53
Unknown (for use when the device problem is not known) 53
Poor Quality Image 49
Break 45
Detachment of Device or Device Component 44

Yearly Trend

94
1994: 2
95
1995: 2
96
1996: 9
97
1997: 15
98
1998: 19
99
1999: 20
00
2000: 25
01
2001: 35
02
2002: 30
03
2003: 34
04
2004: 34
05
2005: 45
06
2006: 60
07
2007: 92
08
2008: 101
09
2009: 132
10
2010: 252
11
2011: 377
12
2012: 77
13
2013: 58
14
2014: 123
15
2015: 36
16
2016: 102
17
2017: 88
18
2018: 49
19
2019: 30
20
2020: 14
21
2021: 29
22
2022: 265
23
2023: 1,204
24
2024: 1,332
25
2025: 2,204
26
2026: 730

Reports rose to 2,204 in 2025, up from an average of 1,268 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, X-Ray, Angiographic

Top Manufacturers

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 5,690
PHILIPS HEALTHCARE 578
PHILIPS MEDICAL SYSTEMS 421

Event Locations

7,064 (92.6%)
HOSPITAL 293 (3.8%)
I 220 (2.9%)
NO INFORMATION 19 (0.2%)
INVALID DATA 18 (0.2%)
NOT APPLICABLE 6 (0.1%)
OTHER 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)

Compare PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs PHILIPS HEALTHCARE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, X-Ray, Angiographic: 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 (7,625 here).

Glucose Oxidase, Glucose 7,604 Nasopharyngoscope 7,691 Device, Microtiter Diluting/Dispensing 7,712 Catheter, Embolectomy 7,736

Similar death-typed counts

Nearest other device types by death-typed report count (85 here), distinct from the volume row.

Pulse-Generator, Pacemaker, External 85 Pump, Infusion, Enteral 85 Surgical Device 86 Thoracolumbosacral Pedicle Screw System 86

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

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