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2026 data FDA MAUDE openFDA FDA Class II

Unit, X-Ray, Intraoral

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 §872.1810 (Dental panel).

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FDA MAUDE casebook

openFDA event book Unit, X-Ray, Intraoral LIGHT-BOOK · MAUDE

#833 of 1000 · 592 reports · 1992–2026

  • BOOK 592 reports
  • RANK #833 of 1000
  • DEATH 0 death-typed
  • INJ 8 injury-typed
  • MALF 500 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 306
  • PHOTO Centrifuges For Clini…

Nearest event-volume peer: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (0 report gap)

Unit, X-Ray, Intraoral sits #833 of 1000 among tracked device types with 592 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Unit, X-Ray, Intraoral carries 1.4% INJURY-coded reports, 28.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.4% corpus 30.3% · below corpus mean (-28.9 pp)
  • MALF 84.5% corpus 64.8% · above corpus mean (+19.6 pp)

Lead product-problem code Poor Quality Image is 27% of coded problems · Top event location is 84% of location-tagged rows .

Unit, X-Ray, Intraoral in the event-volume neighbourhood

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

reports

What this shows Unit, X-Ray, Intraoral carries 592 MAUDE reports, ranked #833 of 1000.

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

Event Types

Malfunction 500 (84.5%)
78 (13.2%)
Injury 8 (1.4%)
Other 4 (0.7%)
No answer provided 2 (0.3%)

Patient Outcomes

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

559 (95.9%)
Other 15 (2.6%)
Required Intervention 4 (0.7%)
Hospitalization 2 (0.3%)
R 1 (0.2%)
S 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Poor Quality Image 196
Component(s), broken 137
Break 77
Communication or Transmission Problem 57
Component Falling 51
Failure to Transmit Record 48
Collapse 32
Patient Data Problem 28
Intermittent Communication Failure 16
Image Display Error/Artifact 14
Unintended Collision 14
Detachment Of Device Component 10
Crack 9
Failure to Read Input Signal 7
Device Tipped Over 6
Display or Visual Feedback Problem 6
Detachment of Device or Device Component 4
Improper or Incorrect Procedure or Method 4
Unintended System Motion 4
Cable break 2

Yearly Trend

92
1992: 1
95
1995: 2
96
1996: 5
97
1997: 9
98
1998: 10
99
1999: 41
00
2000: 27
01
2001: 21
02
2002: 50
03
2003: 30
04
2004: 29
05
2005: 2
06
2006: 9
07
2007: 6
08
2008: 18
09
2009: 2
18
2018: 5
19
2019: 3
21
2021: 1
22
2022: 2
23
2023: 12
25
2025: 1
26
2026: 306

Reports fell to 1 in 2025, down from an average of 7 in the two years before.

Related Entities for Unit, X-Ray, Intraoral

Event Locations

500 (84.5%)
NOT APPLICABLE 65 (11.0%)
INVALID DATA 8 (1.4%)
I 7 (1.2%)
OUTPATIENT TREATMENT FACILITY 4 (0.7%)
NO INFORMATION 3 (0.5%)
OTHER 3 (0.5%)
HOSPITAL 1 (0.2%)
UNKNOWN 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Unit, X-Ray, Intraoral carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (592 here).

Centrifuges For Clinical Use 592 Mixer 590 Chair, Adjustable, Mechanical 586 Mesh, Surgical, Absorbable, Abdominal Hernia 586

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Unit, X-Ray, Intraoral 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 Unit, X-Ray, Intraoral; 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.