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Table, Radiologic

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FDA MAUDE adverse event data · 1993–2025

What the Data Shows About Table, Radiologic

The FDA MAUDE database aggregates 418 adverse-event reports for Table, Radiologic spanning the period from 1993 through 2025. Of these, 7 are classified as death reports, 68 as injury reports, and 307 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 11 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Unintended Movement topping the list at 60 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 33 years of MAUDE data, with the peak single-year volume reaching 55 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 10 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

418
Total Reports
7
Death Reports
68
Injury Reports
307
Malfunctions

Event Types

Malfunction 307 (73.4%)
Injury 68 (16.3%)
Other 30 (7.2%)
Death 7 (1.7%)
6 (1.4%)

Patient Outcomes

261 (60.4%)
Other 106 (24.5%)
Required Intervention 28 (6.5%)
Hospitalization 13 (3.0%)
R 7 (1.6%)
Death 6 (1.4%)
Life Threatening 4 (0.9%)
L 3 (0.7%)
O 2 (0.5%)
H 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Unintended Movement 60
Fluid/Blood Leak 29
Mechanical Problem 9
Unintended System Motion 7
Device Maintenance Issue 5
Loose or Intermittent Connection 5
Positioning Failure 5
Device Operates Differently Than Expected 4
Device Slipped 4
Difficult or Delayed Positioning 4
Insufficient Information 4
Positioning Problem 4
Break 3
Device Fell 3
Mechanics Altered 3
Device Sensing Problem 2
Failure to Sense 2
Power Problem 2
Use of Device Problem 2
Adverse Event Without Identified Device or Use Problem 1

Yearly Trend

93
1993: 3
94
1994: 13
95
1995: 7
96
1996: 19
97
1997: 55
98
1998: 12
99
1999: 12
00
2000: 10
01
2001: 8
02
2002: 6
03
2003: 6
04
2004: 8
05
2005: 8
06
2006: 16
07
2007: 14
08
2008: 40
09
2009: 6
10
2010: 5
11
2011: 19
12
2012: 5
13
2013: 5
14
2014: 1
15
2015: 2
16
2016: 1
17
2017: 12
18
2018: 31
19
2019: 4
20
2020: 2
21
2021: 9
22
2022: 50
23
2023: 12
24
2024: 8
25
2025: 9

Related Entities for Table, Radiologic

Event Locations

216 (51.7%)
HOSPITAL 117 (28.0%)
I 50 (12.0%)
INVALID DATA 15 (3.6%)
OUTPATIENT DIAGNOSTIC FACILITY 8 (1.9%)
NO INFORMATION 3 (0.7%)
OUTPATIENT TREATMENT FACILITY 3 (0.7%)
UNKNOWN 3 (0.7%)
NOT APPLICABLE 2 (0.5%)
OTHER 1 (0.2%)

Compare IMRIS - DEERFIELD IMAGING, INC. vs IMRIS - DEERFIELD IMAGING, INC →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.