2026 data FDA MAUDE openFDA

Interventional Fluoroscopic X-Ray System

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 MAUDE casebook

openFDA event book Interventional Fluoroscopic X-Ray System MID-BOOK · MAUDE

#70 of 1000 · 47,993 reports · 2004–2026

  • BOOK 47,993 reports
  • RANK #70 of 1000
  • DEATH 99 death-typed
  • INJ 580 injury-typed
  • MALF 47,249 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 14,141
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (909 report gap)

Interventional Fluoroscopic X-Ray System sits #70 of 1000 among tracked device types with 47,993 MAUDE reports spanning 2004–2026. 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 →

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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 1.2% corpus 30.4% · below corpus mean (-29.2 pp)
  • MALF 98.4% corpus 64.5% · above corpus mean (+33.9 pp)

Lead product-problem code Activation Failure is 26% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. accounts for 61% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Interventional Fluoroscopic X-Ray System in the event-volume neighbourhood

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

reports

What this shows Interventional Fluoroscopic X-Ray System carries 47,993 MAUDE reports, ranked #70 of 1000.

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

Event Types

Malfunction 47,249 (98.4%)
Injury 580 (1.2%)
Death 99 (0.2%)
No answer provided 44 (0.1%)
16 (0.0%)
Other 5 (0.0%)

Patient Outcomes

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

46,988 (97.8%)
Other 630 (1.3%)
Required Intervention 152 (0.3%)
Death 116 (0.2%)
Hospitalization 42 (0.1%)
R 27 (0.1%)
Life Threatening 22 (0.0%)
O 21 (0.0%)
L 17 (0.0%)
H 4 (0.0%)
Disability 4 (0.0%)
D 3 (0.0%)
S 1 (0.0%)

Top Product Problems

Activation Failure 11,881
Radiation Output Failure 10,071
Application Program Freezes, Becomes Nonfunctional 4,267
Positioning Failure 3,563
Device Inoperable 2,673
No Display/Image 2,049
Device Operates Differently Than Expected 1,208
Positioning Problem 1,192
Device Stops Intermittently 1,175
Device Displays Incorrect Message 1,137
Communication or Transmission Problem 838
Failure to Advance 831
Noise, Audible 771
Failure to Power Up 699
Device Sensing Problem 652
Use of Device Problem 629
Poor Quality Image 593
Electrical /Electronic Property Problem 550
Mechanical Problem 473
Application Program Problem 450

Yearly Trend

04
2004: 1
07
2007: 1
11
2011: 1
12
2012: 1
13
2013: 27
14
2014: 103
15
2015: 2,134
16
2016: 4,074
17
2017: 1,604
18
2018: 1,449
19
2019: 1,558
20
2020: 1,581
21
2021: 1,981
22
2022: 2,932
23
2023: 7,604
24
2024: 7,942
25
2025: 14,141
26
2026: 859

Related Entities for Interventional Fluoroscopic X-Ray System

Event Locations

34,373 (71.6%)
I 13,024 (27.1%)
HOSPITAL 431 (0.9%)
NO INFORMATION 161 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OTHER 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs GE OEC MEDICAL SYSTEMS (SLC) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Interventional Fluoroscopic X-Ray System, 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 (47,993 here).

Similar death-typed counts

Nearest other device types by death-typed report count (99 here), distinct from the volume row.

Disclaimer: MAUDE figures for Interventional Fluoroscopic X-Ray 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 Interventional Fluoroscopic X-Ray 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.