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2026 data FDA MAUDE openFDA

System, Image Processing, Radiological

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, Image Processing, Radiological MID-BOOK · MAUDE

#137 of 1000 · 19,390 reports · 1996–2026

  • BOOK 19,390 reports
  • RANK #137 of 1000
  • DEATH 40 death-typed
  • INJ 115 injury-typed
  • MALF 19,123 malfunction
  • SPAN 1996–2026
  • PEAK 2014: 15,631
  • PHOTO Orthopedic Stereotaxi…

Nearest event-volume peer: Orthopedic Stereotaxic Instrument (223 report gap)

System, Image Processing, Radiological sits #137 of 1000 among tracked device types with 19,390 MAUDE reports spanning 1996–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 0.6% corpus 30.4% · below corpus mean (-29.8 pp)
  • MALF 98.6% corpus 64.5% · above corpus mean (+34.1 pp)

Lead product-problem code Computer Software Problem is 24% of coded problems · Lead manufacturer AGFA HEALTHCARE CORP accounts for 62% of manufacturer-tagged reports · Top event location is 96% of location-tagged rows .

System, Image Processing, Radiological in the event-volume neighbourhood

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

reports

What this shows System, Image Processing, Radiological carries 19,390 MAUDE reports, ranked #137 of 1000.

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

Event Types

Malfunction 19,123 (98.6%)
Injury 115 (0.6%)
Other 81 (0.4%)
Death 40 (0.2%)
31 (0.2%)

Patient Outcomes

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

18,988 (97.8%)
Other 286 (1.5%)
Required Intervention 43 (0.2%)
Death 42 (0.2%)
Hospitalization 14 (0.1%)
R 7 (0.0%)
Life Threatening 7 (0.0%)
O 6 (0.0%)
Disability 6 (0.0%)
H 4 (0.0%)
Congenital Anomaly 2 (0.0%)
L 1 (0.0%)

Top Product Problems

Computer Software Problem 260
Loss of Data 151
Data Problem 117
Use of Device Problem 81
Patient Data Problem 57
Application Program Problem: Parameter Calculation Error 49
Application Program Problem 47
Device Operates Differently Than Expected 47
Poor Quality Image 42
Adverse Event Without Identified Device or Use Problem 40
Device Issue 37
Improper or Incorrect Procedure or Method 31
No Apparent Adverse Event 20
Device Operational Issue 18
Insufficient Information 15
Incorrect Measurement 13
No Display/Image 13
Incorrect, Inadequate or Imprecise Result or Readings 12
Failure to Transmit Record 11
Use of Incorrect Control/Treatment Settings 11

Yearly Trend

96
1996: 1
97
1997: 2
98
1998: 2
99
1999: 4
00
2000: 9
01
2001: 12
02
2002: 10
03
2003: 41
04
2004: 11
05
2005: 13
06
2006: 21
07
2007: 152
08
2008: 154
09
2009: 145
10
2010: 145
11
2011: 454
12
2012: 266
13
2013: 1,130
14
2014: 15,631
15
2015: 211
16
2016: 290
17
2017: 104
18
2018: 72
19
2019: 88
20
2020: 82
21
2021: 70
22
2022: 28
23
2023: 26
24
2024: 42
25
2025: 133
26
2026: 41

Related Entities for System, Image Processing, Radiological

Top Manufacturers

AGFA HEALTHCARE CORP 8,972
AGFA HEALTHCARE CORP. 4,921
GE OEC MEDICAL SYSTEMS (SLC) 667

Event Locations

18,550 (95.7%)
I 708 (3.7%)
HOSPITAL 80 (0.4%)
NO INFORMATION 16 (0.1%)
OTHER 11 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 11 (0.1%)
INVALID DATA 8 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare AGFA HEALTHCARE CORP vs AGFA HEALTHCARE CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Image Processing, Radiological, 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 (19,390 here).

Orthopedic Stereotaxic Instrument 19,167 Duodenoscope And Accessories, Flexible/Rigid 19,614 Catheter, Intravascular, Diagnostic 19,752 Dorsal Root Ganglion Stimulator For Pain Re… 18,878

Similar death-typed counts

Nearest other device types by death-typed report count (40 here), distinct from the volume row.

Appliance, Fixation, Spinal Interlaminal 40 Applier, Surgical, Clip 40 Pacemaker Lead Adaptor 40 Prosthesis, Hip, Femoral, Resurfacing 40

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

Disclaimer: MAUDE figures for System, Image Processing, Radiological 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, Image Processing, Radiological; 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.