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2025 data FDA MAUDE openFDA FDA Class II

Table, Radiologic

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 §892.1980 (Radiology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Table, Radiologic LIGHT-BOOK · MAUDE

#952 of 1000 · 418 reports · 1993–2025

  • BOOK 418 reports
  • RANK #952 of 1000
  • DEATH 7 death-typed
  • INJ 68 injury-typed
  • MALF 307 malfunction
  • SPAN 1993–2025
  • PEAK 1997: 55
  • PHOTO Fibrin Sealant Prepar…

Nearest event-volume peer: Fibrin Sealant Preparation Device (1 report gap)

Table, Radiologic sits #952 of 1000 among tracked device types with 418 MAUDE reports spanning 1993–2025. 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 →

Injury-coded reports sit below the device-type norm

Table, Radiologic carries 16.3% INJURY-coded reports, 14.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 16.3% corpus 30.3% · below corpus mean (-14.0 pp)
  • MALF 73.4% corpus 64.8% · above corpus mean (+8.6 pp)

Lead product-problem code Unintended Movement is 19% of coded problems · Lead manufacturer GE OEC MEDICAL SYSTEMS INC. accounts for 45% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Table, Radiologic in the event-volume neighbourhood

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

reports

What this shows Table, Radiologic carries 418 MAUDE reports, ranked #952 of 1000.

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

Event Types

Malfunction 307 (73.4%)
Injury 68 (16.3%)
Other 30 (7.2%)
Death 7 (1.7%)
6 (1.4%)

Patient Outcomes

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

261 (60.4%)
Other 106 (24.5%)
Required Intervention 28 (6.5%)
Hospitalization 13 (3.0%)
R 7 (1.6%)
Death 6 (1.4%)
Life Threatening 4 (0.9%)
L 3 (0.7%)
O 2 (0.5%)
H 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Unintended Movement 61
Fluid/Blood Leak 29
Detachment Of Device Component 22
Unintended System Motion 20
Sticking 17
Device Slipped 16
Unknown (for use when the device problem is not known) 16
Design/structure problem 15
Break 13
Mechanical Problem 12
System fails to activate 12
Component Falling 11
Device Inoperable 10
Use of Device Problem 10
Collapse 9
Device Operates Differently Than Expected 9
Device Issue 8
Loose or Intermittent Connection 8
Other (for use when an appropriate device code cannot be identified) 8
Insufficient Device Problem Information 7

Yearly Trend

93
1993: 3
94
1994: 13
95
1995: 7
96
1996: 19
97
1997: 55
98
1998: 12
99
1999: 12
00
2000: 10
01
2001: 8
02
2002: 6
03
2003: 6
04
2004: 8
05
2005: 8
06
2006: 16
07
2007: 14
08
2008: 40
09
2009: 6
10
2010: 5
11
2011: 19
12
2012: 5
13
2013: 5
14
2014: 1
15
2015: 2
16
2016: 1
17
2017: 12
18
2018: 31
19
2019: 4
20
2020: 2
21
2021: 9
22
2022: 50
23
2023: 12
24
2024: 8
25
2025: 9

Reports fell to 8 in 2024, down from an average of 31 in the two years before.

Related Entities for Table, Radiologic

Top Manufacturers

GE OEC MEDICAL SYSTEMS INC. 23
PHILIPS MEDICAL SYSTEMS 15
GE OEC MEDICAL SYSTEMS (SLC) 13

Event Locations

216 (51.7%)
HOSPITAL 117 (28.0%)
I 50 (12.0%)
INVALID DATA 15 (3.6%)
OUTPATIENT DIAGNOSTIC FACILITY 8 (1.9%)
NO INFORMATION 3 (0.7%)
OUTPATIENT TREATMENT FACILITY 3 (0.7%)
UNKNOWN 3 (0.7%)
NOT APPLICABLE 2 (0.5%)
OTHER 1 (0.2%)

Compare GE OEC MEDICAL SYSTEMS INC. vs PHILIPS MEDICAL SYSTEMS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Table, Radiologic: 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 (418 here).

Fibrin Sealant Preparation Device 419 System, Gastrointestinal Motility 417 Stimulator, Carotid Sinus Nerve 416 Cuff, Tracheal Tube, Inflatable 421

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

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

Disclaimer: MAUDE figures for Table, Radiologic 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 Table, Radiologic; 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.