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2026 data FDA MAUDE openFDA FDA Class II

System, X-Ray, Stationary

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).

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FDA MAUDE casebook

openFDA event book System, X-Ray, Stationary LIGHT-BOOK · MAUDE

#621 of 1000 · 1,218 reports · 1995–2026

  • BOOK 1,218 reports
  • RANK #621 of 1000
  • DEATH 5 death-typed
  • INJ 152 injury-typed
  • MALF 947 malfunction
  • SPAN 1995–2026
  • PEAK 2007: 120
  • PHOTO Hemodialyzer

Nearest event-volume peer: Hemodialyzer, Re-Use, High Flux (1 report gap)

System, X-Ray, Stationary sits #621 of 1000 among tracked device types with 1,218 MAUDE reports spanning 1995–2026. 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 →

Injury-coded reports sit below the device-type norm

System, X-Ray, Stationary carries 12.5% INJURY-coded reports, 17.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 12.5% corpus 30.3% · below corpus mean (-17.8 pp)
  • MALF 77.8% corpus 64.8% · above corpus mean (+12.9 pp)

Lead product-problem code Break is 12% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 100% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

System, X-Ray, Stationary in the event-volume neighbourhood

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

reports

What this shows System, X-Ray, Stationary carries 1,218 MAUDE reports, ranked #621 of 1000.

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

Event Types

Malfunction 947 (77.8%)
Injury 152 (12.5%)
Other 69 (5.7%)
No answer provided 37 (3.0%)
8 (0.7%)
Death 5 (0.4%)

Patient Outcomes

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

942 (76.5%)
Other 205 (16.7%)
Required Intervention 44 (3.6%)
Hospitalization 13 (1.1%)
R 8 (0.6%)
Life Threatening 6 (0.5%)
O 3 (0.2%)
Death 3 (0.2%)
S 2 (0.2%)
Disability 2 (0.2%)
D 1 (0.1%)
H 1 (0.1%)
N 1 (0.1%)

Top Product Problems

Break 135
Unintended System Motion 106
Component Falling 101
Unintended Movement 77
Device Operational Issue 73
Nonstandard Device 73
Use of Device Problem 63
Detachment Of Device Component 51
Device Slipped 48
Device Fell 45
Defective Component 43
Device Issue 41
Improper or Incorrect Procedure or Method 39
Sticking 38
Computer Software Problem 36
Device Operates Differently Than Expected 36
Device Handling Problem 33
Locking mechanism failure 32
Detachment of Device or Device Component 30
Mechanical Problem 30

Yearly Trend

95
1995: 1
96
1996: 6
97
1997: 4
98
1998: 13
99
1999: 10
00
2000: 9
01
2001: 20
02
2002: 7
03
2003: 9
04
2004: 10
05
2005: 23
06
2006: 46
07
2007: 120
08
2008: 95
09
2009: 61
10
2010: 82
11
2011: 103
12
2012: 74
13
2013: 24
14
2014: 34
15
2015: 59
16
2016: 18
17
2017: 31
18
2018: 36
19
2019: 77
20
2020: 41
21
2021: 37
22
2022: 27
23
2023: 39
24
2024: 34
25
2025: 40
26
2026: 28

Reports in 2025 (40) held close to the prior two-year average of 37.

Related Entities for System, X-Ray, Stationary

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 74

Event Locations

886 (72.7%)
I 137 (11.2%)
NO INFORMATION 88 (7.2%)
HOSPITAL 80 (6.6%)
OUTPATIENT DIAGNOSTIC FACILITY 14 (1.1%)
INVALID DATA 8 (0.7%)
OUTPATIENT TREATMENT FACILITY 4 (0.3%)
OTHER 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, X-Ray, Stationary: 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 (1,218 here).

Hemodialyzer, Re-Use, High Flux 1,219 Accessories, Blood Circuit, Hemodialysis 1,220 Cardiovascular Procedure Kit 1,221 Lithotriptor, Ultrasonic 1,213

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

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

Disclaimer: MAUDE figures for System, X-Ray, Stationary 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, X-Ray, Stationary; 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.