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2026 data FDA MAUDE openFDA FDA Class II

Image-Intensified Fluoroscopic X-Ray System, Mobile

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 Image-Intensified Fluoroscopic X-Ray System MID-BOOK · MAUDE

#206 of 1000 · 10,986 reports · 2012–2026

  • BOOK 10,986 reports
  • RANK #206 of 1000
  • DEATH 8 death-typed
  • INJ 285 injury-typed
  • MALF 10,683 malfunction
  • SPAN 2012–2026
  • PEAK 2016: 3,820
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Continuous, Non-Life-Supporting (209 report gap)

Image-Intensified Fluoroscopic X-Ray System, Mobile sits #206 of 1000 among tracked device types with 10,986 MAUDE reports spanning 2012–2026. 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

Image-Intensified Fluoroscopic X-Ray System carries 97.2% MALFUNCTION-coded reports, 32.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 2.6% corpus 30.3% · below corpus mean (-27.7 pp)
  • MALF 97.2% corpus 64.8% · above corpus mean (+32.4 pp)

Lead product-problem code Device Operates Differently Than Expected is 24% of coded problems · Lead manufacturer MEDTRONIC NAVIGATION, INC. (LITTLETON) accounts for 64% of manufacturer-tagged reports · Top event location I is 89% of location-tagged rows .

Image-Intensified 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 Image-Intensified Fluoroscopic X-Ray System, Mobile carries 10,986 MAUDE reports, ranked #206 of 1000.

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

Event Types

Malfunction 10,683 (97.2%)
Injury 285 (2.6%)
Death 8 (0.1%)
4 (0.0%)
No answer provided 3 (0.0%)
Other 3 (0.0%)

Patient Outcomes

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

10,656 (96.6%)
Required Intervention 207 (1.9%)
Other 78 (0.7%)
R 24 (0.2%)
Hospitalization 22 (0.2%)
H 14 (0.1%)
Death 7 (0.1%)
O 6 (0.1%)
S 5 (0.0%)
D 2 (0.0%)
Disability 2 (0.0%)
Life Threatening 2 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Device Operates Differently Than Expected 3,479
Electrical /Electronic Property Problem 1,838
Application Program Freezes or Fails to Launch 1,769
Device Displays Incorrect Message 1,172
Communication or Transmission Problem 1,093
Device Inoperable 1,085
Computer Software Problem 508
Poor Quality Image 408
Difficult to Open or Close 386
Positioning Problem 384
Mechanical Problem 363
Unexpected Shutdown 270
Device Stops Intermittently 258
Failure to Run on Battery 257
Material Deformation 256
Failure to Power Up 242
Application Interface Becomes Non-Functional Or Program Exits Abnormally 241
Adverse Event Without Identified Device or Use Problem 231
Imprecision 231
Display or Visual Feedback Problem 202

Yearly Trend

12
2012: 5
13
2013: 41
14
2014: 89
15
2015: 97
16
2016: 3,820
17
2017: 1,697
18
2018: 1,647
19
2019: 1,297
20
2020: 816
21
2021: 554
22
2022: 295
23
2023: 275
24
2024: 192
25
2025: 124
26
2026: 37

Reports fell to 124 in 2025, down from an average of 234 in the two years before.

Related Entities for Image-Intensified Fluoroscopic X-Ray System, Mobile

Top Manufacturers

MEDTRONIC NAVIGATION, INC. (LITTLETON) 6,884
MEDTRONIC NAVIGATION, INC (LITTLETON) 3,750
MEDTRONIC NAVIGATION, INC 99
MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 19
HOLOGIC, INC. 11
MEDTRONIC NAVIGATION, INC. 10

Event Locations

I 9,765 (88.9%)
1,180 (10.7%)
HOSPITAL 33 (0.3%)
NO INFORMATION 8 (0.1%)

Compare MEDTRONIC NAVIGATION, INC. (LITTLETON) vs MEDTRONIC NAVIGATION, INC (LITTLETON) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Image-Intensified 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 (10,986 here).

Ventilator, Continuous, Non-Life-Supporting 11,195 Recorder, Event, Implantable Cardiac, 11,214 Compressor, Cardiac, External 11,220 Ligator, Esophageal 10,683

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Bronchoscope Accessory 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8

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

Disclaimer: MAUDE figures for Image-Intensified 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 Image-Intensified 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.