PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

System, X-Ray, Mobile

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 §892.1720 (Radiology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#686 of 1000 · 922 reports · 1992–2026

  • BOOK 922 reports
  • RANK #686 of 1000
  • DEATH 8 death-typed
  • INJ 158 injury-typed
  • MALF 701 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 118
  • PHOTO Bed, Manual

Nearest event-volume peer: Bed, Manual (6 report gap)

System, X-Ray, Mobile sits #686 of 1000 among tracked device types with 922 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 →

Injury-coded reports sit below the device-type norm

System, X-Ray, Mobile carries 17.1% INJURY-coded reports, 13.2pp 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 17.1% corpus 30.3% · below corpus mean (-13.2 pp)
  • MALF 76.0% corpus 64.8% · above corpus mean (+11.2 pp)

Lead product-problem code Unintended Movement is 13% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 58% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

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

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

reports

What this shows System, X-Ray, Mobile carries 922 MAUDE reports, ranked #686 of 1000.

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

Event Types

Malfunction 701 (76.0%)
Injury 158 (17.1%)
Other 26 (2.8%)
No answer provided 15 (1.6%)
14 (1.5%)
Death 8 (0.9%)

Patient Outcomes

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

671 (72.3%)
Other 162 (17.5%)
Required Intervention 36 (3.9%)
Life Threatening 26 (2.8%)
Hospitalization 12 (1.3%)
Death 8 (0.9%)
R 5 (0.5%)
Disability 3 (0.3%)
L 2 (0.2%)
O 1 (0.1%)
S 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Unintended Movement 99
Unintended System Motion 73
Device Operates Differently Than Expected 57
Break 44
Device Displays Incorrect Message 43
Use of Device Problem 39
Component Falling 37
Computer Operating System Problem 36
Nonstandard Device 36
Smoking 35
Loss of Power 32
Detachment Of Device Component 30
No Display/Image 30
Mechanical Problem 28
Detachment of Device or Device Component 24
Operating System Version or Upgrade Problem 23
Device Issue 22
Device Emits Odor 20
Device Inoperable 20
Improper or Incorrect Procedure or Method 20

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 2
95
1995: 4
96
1996: 4
97
1997: 12
98
1998: 17
99
1999: 9
00
2000: 12
01
2001: 8
02
2002: 3
03
2003: 5
04
2004: 8
05
2005: 14
06
2006: 8
07
2007: 16
08
2008: 27
09
2009: 35
10
2010: 75
11
2011: 118
12
2012: 24
13
2013: 17
14
2014: 51
15
2015: 30
16
2016: 33
17
2017: 35
18
2018: 27
19
2019: 40
20
2020: 48
21
2021: 47
22
2022: 32
23
2023: 77
24
2024: 39
25
2025: 27
26
2026: 16

Reports fell to 27 in 2025, down from an average of 58 in the two years before.

Related Entities for System, X-Ray, Mobile

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 106
PHILIPS HEALTHCARE 78

Event Locations

537 (58.2%)
HOSPITAL 168 (18.2%)
I 161 (17.5%)
NO INFORMATION 27 (2.9%)
INVALID DATA 14 (1.5%)
NOT APPLICABLE 7 (0.8%)
OTHER 4 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare PHILIPS MEDICAL SYSTEMS vs PHILIPS HEALTHCARE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, X-Ray, Mobile: 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 (922 here).

Bed, Manual 928 Absorbable Coronary Drug-Eluting Stent 929 Appliance 910 Device 909

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Bronchoscope Accessory 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8

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

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