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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §892.1650 (Radiology panel).

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FDA MAUDE casebook

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

#71 of 1000 · 49,982 reports · 2004–2026

  • BOOK 49,982 reports
  • RANK #71 of 1000
  • DEATH 105 death-typed
  • INJ 599 injury-typed
  • MALF 49,212 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 14,140
  • PHOTO Instrument

Nearest event-volume peer: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (285 report gap)

Interventional Fluoroscopic X-Ray System sits #71 of 1000 among tracked device types with 49,982 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 →

Malfunction reports run above the device-type norm

Interventional Fluoroscopic X-Ray System carries 98.5% MALFUNCTION-coded reports, 33.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 1.2% corpus 30.3% · below corpus mean (-29.1 pp)
  • MALF 98.5% corpus 64.8% · above corpus mean (+33.6 pp)

Lead product-problem code Activation Failure is 25% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. accounts for 62% of manufacturer-tagged reports · Top event location is 73% 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 49,982 MAUDE reports, ranked #71 of 1000.

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

Event Types

Malfunction 49,212 (98.5%)
Injury 599 (1.2%)
Death 105 (0.2%)
No answer provided 45 (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.

48,250 (97.9%)
Other 644 (1.3%)
Required Intervention 154 (0.3%)
Death 122 (0.2%)
Hospitalization 42 (0.1%)
R 26 (0.1%)
O 21 (0.0%)
Life Threatening 21 (0.0%)
L 17 (0.0%)
D 4 (0.0%)
H 4 (0.0%)
Disability 4 (0.0%)
S 1 (0.0%)

Top Product Problems

Activation Failure 12,685
Radiation Output Failure 10,505
Application Program Freezes or Fails to Launch 4,301
Positioning Failure 3,813
Device Inoperable 3,711
No Display/Image 2,127
Device Stops Intermittently 1,711
Device Displays Incorrect Message 1,701
Device Operates Differently Than Expected 1,265
Positioning Problem 1,208
Failure to Power Up 964
Failure to Advance 953
Communication or Transmission Problem 857
Noise, Audible 787
Device Sensing Problem 657
Use of Device Problem 640
Poor Quality Image 617
Electrical /Electronic Property Problem 556
Mechanical Problem 522
Application Program Problem 473

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: 14,140
26
2026: 2,849

Reports rose to 14,140 in 2025, up from an average of 7,773 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Interventional Fluoroscopic X-Ray System

Top Manufacturers

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 28,741
GE OEC MEDICAL SYSTEMS (SLC) 6,108
MEDTRONIC NAVIGATION, INC (LITTLETON) 4,849
SANMINA -SCI SYSTEMS 4,437
MEDTRONIC NAVIGATION, INC. (LITTLETON) 2,097
PHILIPS HEALTHCARE 259

Event Locations

36,357 (72.7%)
I 13,024 (26.1%)
HOSPITAL 435 (0.9%)
NO INFORMATION 162 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Interventional Fluoroscopic X-Ray 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 (49,982 here).

Instrument 50,267 Catheter 48,999 Tubes 48,656 Stimulator 51,898

Similar death-typed counts

Nearest other device types by death-typed report count (105 here), distinct from the volume row.

Stent, Colonic, Metallic, Expandable 105 Catheter, Septostomy 104 Neurological Stereotaxic Instrument 104 Separator 106

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

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.