2026 data FDA MAUDE openFDA FDA Class II

Solid State X-Ray Imager (Flat Panel/Digital Imager)

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 §892.1680 (Radiology panel).

FDA MAUDE casebook

openFDA event book Solid State X-Ray Imager LIGHT-BOOK · MAUDE

#607 of 1000 · 1,277 reports · 1997–2026

  • BOOK 1,277 reports
  • RANK #607 of 1000
  • DEATH 11 death-typed
  • INJ 104 injury-typed
  • MALF 1,042 malfunction
  • SPAN 1997–2026
  • PEAK 2012: 267
  • PHOTO Stylet, Catheter

Nearest event-volume peer: Stylet, Catheter (2 report gap)

Solid State X-Ray Imager (Flat Panel/Digital Imager) sits #607 of 1000 among tracked device types with 1,277 MAUDE reports spanning 1997–2026. 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Solid State X-Ray Imager carries 8.1% INJURY-coded reports, 22.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 8.1% corpus 30.3% · below corpus mean (-22.1 pp)
  • MALF 81.6% corpus 64.8% · above corpus mean (+16.8 pp)

Lead product-problem code Image Display Error/Artifact is 17% of coded problems · Top event location is 80% of location-tagged rows .

Solid State X-Ray Imager in the event-volume neighbourhood

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

reports

What this shows Solid State X-Ray Imager (Flat Panel/Digital Imager) carries 1,277 MAUDE reports, ranked #607 of 1000.

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

Event Types

Malfunction 1,042 (81.6%)
Injury 104 (8.1%)
No answer provided 77 (6.0%)
Other 31 (2.4%)
12 (0.9%)
Death 11 (0.9%)

Patient Outcomes

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

1,094 (84.5%)
Other 129 (10.0%)
Required Intervention 22 (1.7%)
R 13 (1.0%)
Death 11 (0.8%)
Hospitalization 11 (0.8%)
Life Threatening 7 (0.5%)
L 4 (0.3%)
Disability 2 (0.2%)
O 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Image Display Error/Artifact 229
Device Fell 219
Device Handling Problem 214
Device Displays Incorrect Message 103
Device Operational Issue 80
Detachment of Device or Device Component 74
Device Operates Differently Than Expected 62
Poor Quality Image 58
Device Slipped 48
Component Falling 33
Loss of Data 29
No Display/Image 24
Improper or Incorrect Procedure or Method 23
Insufficient Device Problem Information 23
Migration or Expulsion of Device 23
Unintended System Motion 23
Repair 22
Unintended Movement 19
Break 17
Use of Device Problem 15

Yearly Trend

97
1997: 2
02
2002: 1
03
2003: 1
04
2004: 4
05
2005: 30
06
2006: 18
07
2007: 25
08
2008: 30
09
2009: 34
10
2010: 39
11
2011: 101
12
2012: 267
13
2013: 159
14
2014: 29
15
2015: 21
16
2016: 26
17
2017: 20
18
2018: 84
19
2019: 45
20
2020: 9
21
2021: 26
22
2022: 13
23
2023: 51
24
2024: 91
25
2025: 142
26
2026: 9

Reports rose to 142 in 2025, up from an average of 71 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Solid State X-Ray Imager (Flat Panel/Digital Imager)

Event Locations

1,021 (80.0%)
I 128 (10.0%)
NO INFORMATION 84 (6.6%)
HOSPITAL 41 (3.2%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.2%)
OTHER 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Solid State X-Ray Imager: 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 (1,277 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Solid State X-Ray Imager 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 Solid State X-Ray Imager; 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.