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2026 data FDA MAUDE openFDA

System, X-Ray, Fluoroscopic, Image-Intensified

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.

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FDA MAUDE casebook

openFDA event book System MID-BOOK · MAUDE

#41 of 1000 · 90,588 reports · 1992–2026

  • BOOK 90,588 reports
  • RANK #41 of 1000
  • DEATH 20 death-typed
  • INJ 217 injury-typed
  • MALF 90,146 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 14,000
  • PHOTO Bed

Nearest event-volume peer: Bed, Ac-Powered Adjustable Hospital (1,801 report gap)

System, X-Ray, Fluoroscopic, Image-Intensified sits #41 of 1000 among tracked device types with 90,588 MAUDE reports spanning 1992–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.2% corpus 30.4% · below corpus mean (-30.2 pp)
  • MALF 99.5% corpus 64.5% · above corpus mean (+35.0 pp)

Lead product-problem code Device Operational Issue is 23% of coded problems · Lead manufacturer GE OEC MEDICAL SYSTEMS (SLC) accounts for 56% of manufacturer-tagged reports · Top event location is 98% 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, X-Ray, Fluoroscopic, Image-Intensified carries 90,588 MAUDE reports, ranked #41 of 1000.

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

Event Types

Malfunction 90,146 (99.5%)
Injury 217 (0.2%)
Other 81 (0.1%)
72 (0.1%)
No answer provided 52 (0.1%)
Death 20 (0.0%)

Patient Outcomes

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

90,049 (99.4%)
Other 397 (0.4%)
Required Intervention 66 (0.1%)
Hospitalization 35 (0.0%)
R 25 (0.0%)
Death 19 (0.0%)
Life Threatening 14 (0.0%)
O 11 (0.0%)
S 6 (0.0%)
Disability 5 (0.0%)
L 4 (0.0%)
H 2 (0.0%)
Congenital Anomaly 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Device Operational Issue 75
Use of Device Problem 40
Unintended Movement 28
Detachment of Device or Device Component 25
Device Operates Differently Than Expected 18
Device Fell 12
Mechanical Problem 12
No Display/Image 12
Break 11
Poor Quality Image 11
Unintended System Motion 11
Adverse Event Without Identified Device or Use Problem 10
Device Displays Incorrect Message 9
Display or Visual Feedback Problem 9
Insufficient Information 9
Detachment Of Device Component 8
Component Falling 7
Output Problem 7
Device Handling Problem 6
Radiation Output Failure 6

Yearly Trend

92
1992: 3
93
1993: 1
94
1994: 10
95
1995: 15
96
1996: 19
97
1997: 57
98
1998: 49
99
1999: 47
00
2000: 51
01
2001: 52
02
2002: 32
03
2003: 18
04
2004: 24
05
2005: 56
06
2006: 348
07
2007: 9,517
08
2008: 9,484
09
2009: 12,038
10
2010: 5,803
11
2011: 14,000
12
2012: 11,684
13
2013: 13,706
14
2014: 10,265
15
2015: 2,922
16
2016: 35
17
2017: 56
18
2018: 36
19
2019: 49
20
2020: 39
21
2021: 35
22
2022: 34
23
2023: 41
24
2024: 25
25
2025: 33
26
2026: 4

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

Top Manufacturers

GE OEC MEDICAL SYSTEMS (SLC) 46,639
GE OEC MEDICAL SYSTEMS INC. 23,972
GE OEC MEDICAL SYSTEMS GMBH 6,462
GE OEC MEDICAL SYSTEMS INC 3,063
GE OEC MEDICAL SYSTEMS, INC. 2,471
GE OEC MEDICAL SYSTEMS, INC 891

Event Locations

89,117 (98.4%)
HOSPITAL 357 (0.4%)
HOME 319 (0.4%)
NURSING HOME 260 (0.3%)
NO INFORMATION 145 (0.2%)
I 110 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 75 (0.1%)
OTHER 51 (0.1%)
OUTPATIENT TREATMENT FACILITY 42 (0.0%)
NOT APPLICABLE 40 (0.0%)
PATIENT'S HOME 33 (0.0%)
INVALID DATA 26 (0.0%)
UNKNOWN 7 (0.0%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
CATHETERIZATION SUITE 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare GE OEC MEDICAL SYSTEMS (SLC) vs GE OEC MEDICAL SYSTEMS INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for 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 (90,588 here).

Bed, Ac-Powered Adjustable Hospital 92,389 Pulse Generator, Permanent, Implantable 92,723 Prosthesis 87,564 Laparoscope, General & Plastic Surgery 80,330

Similar death-typed counts

Nearest other device types by death-typed report count (20 here), distinct from the volume row.

Accelerator, Linear, Medical 20 Apparatus 20 Endoscopic Access Overtube 20 Set, I.V. Fluid Transfer 20

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.