PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

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.

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

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book System MID-BOOK · MAUDE

#42 of 1000 · 90,606 reports · 1992–2026

  • BOOK 90,606 reports
  • RANK #42 of 1000
  • DEATH 20 death-typed
  • INJ 220 injury-typed
  • MALF 90,159 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 14,000
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (825 report gap)

System, X-Ray, Fluoroscopic, Image-Intensified sits #42 of 1000 among tracked device types with 90,606 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 →

Malfunction reports run above the device-type norm

System carries 99.5% MALFUNCTION-coded reports, 34.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
  • MALF 99.5% corpus 64.8% · above corpus mean (+34.7 pp)

Lead product-problem code Device Displays Incorrect Message 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 90,606 MAUDE reports, ranked #42 of 1000.

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

Event Types

Malfunction 90,159 (99.5%)
Injury 220 (0.2%)
Other 81 (0.1%)
72 (0.1%)
No answer provided 54 (0.1%)
Death 20 (0.0%)

Patient Outcomes

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

90,061 (99.4%)
Other 399 (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 Displays Incorrect Message 22,317
Computer Operating System Problem 15,718
No Display/Image 9,701
No Device Output 6,745
Device Operates Differently Than Expected 5,213
Device Inoperable 4,491
Application Interface Becomes Non-Functional Or Program Exits Abnormally 4,105
Poor Quality Image 3,694
Failure to Power Up 3,519
Loss of Power 3,042
Computer failure 2,954
Sticking 2,953
Device Issue 2,343
Image Resolution Poor 1,836
Device Stops Intermittently 1,668
Repair 1,405
Failure, intermittent 1,391
Self-Activation or Keying 1,363
Failure to Back-Up 1,325
Image Display Error/Artifact 1,281

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: 12,039
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: 21

Reports in 2025 (33) held close to the prior two-year average of 33.

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 3,064
GE OEC MEDICAL SYSTEMS, INC. 2,472
GE OEC MEDICAL SYSTEMS, INC 891

Event Locations

89,132 (98.4%)
HOSPITAL 359 (0.4%)
HOME 319 (0.4%)
NURSING HOME 260 (0.3%)
NO INFORMATION 147 (0.2%)
I 109 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for 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 (90,606 here).

Prosthesis 89,781 Bed, Ac-Powered Adjustable Hospital 93,774 Pulse Generator, Permanent, Implantable 95,144 Laparoscope, General & Plastic Surgery 83,414

Similar death-typed counts

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

Accelerator, Linear, Medical 20 Set, I.V. Fluid Transfer 20 Transducer, Pressure, Catheter Tip 20 Apparatus 21

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.