Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device table, radiographic, tilting
Product CodeIXR
Regulation Number 892.1980
Device Class 2

MDR Year MDR Reports MDR Events
2014 120 120
2015 82 82
2016 58 58
2017 25 25
2018 17 17
2019 8 8
2020 12 12
2021 5 5
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 143 143
Device Displays Incorrect Message 32 32
Device Inoperable 30 30
No Display/Image 25 25
Unintended Movement 24 24
Mechanical Problem 18 18
Loss of Power 10 10
Detachment Of Device Component 9 9
Computer Operating System Problem 9 9
Positioning Problem 7 7
Failure to Align 7 7
Self-Activation or Keying 7 7
Poor Quality Image 5 5
Component Falling 4 4
Noise, Audible 4 4
Failure to Power Up 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Output Problem 3 3
Communication or Transmission Problem 3 3
Device Operational Issue 3 3
Sticking 3 3
Smoking 3 3
Device Stops Intermittently 3 3
Difficult to Open or Close 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Detachment of Device or Device Component 2 2
Programming Issue 2 2
Difficult To Position 2 2
Optical Problem 2 2
Device Remains Activated 2 2
Improper Device Output 2 2
Failure to Shut Off 2 2
Circuit Failure 2 2
Mechanical Jam 2 2
Unintended System Motion 2 2
Overheating of Device 2 2
No Device Output 2 2
Unintended Collision 2 2
Power Problem 1 1
Computer Software Problem 1 1
Failure to Calibrate 1 1
High Test Results 1 1
Erratic or Intermittent Display 1 1
Device Emits Odor 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Inadequate Service 1 1
Fluid/Blood Leak 1 1
Inadequate User Interface 1 1
Failure to Transmit Record 1 1
Radiation Overexposure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 147 147
No Known Impact Or Consequence To Patient 143 143
No Patient Involvement 14 14
No Information 10 10
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 4 4
Not Applicable 2 2
Injury 2 2
Complaint, Ill-Defined 1 1
Radiation Exposure, Unintended 1 1
Head Injury 1 1
Crushing Injury 1 1
Neck Pain 1 1
Thrombosis 1 1
Fall 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II May-22-2017
2 GE Healthcare, LLC II Dec-23-2016
3 LIEBEL-FLARSHEIM COMPANY LLC II Aug-21-2018
4 Medical Positioning Inc II Apr-13-2011
5 Oakworks Inc II May-23-2019
6 Oakworks Inc II Feb-23-2018
7 Philips Electronics North America Corporation II Aug-01-2016
8 Philips Healthcare Inc. II Aug-15-2012
9 Philips Healthcare Inc. II Jun-18-2012
10 Philips Medical Systems Nederlands II May-03-2018
11 Philips Medical Systems North America Co. Phillips II Sep-13-2010
12 Philips Medical Systems North America Co. Phillips II Mar-23-2010
13 Philips North America, LLC II Mar-13-2020
14 Philips North America, LLC II Mar-23-2019
15 Shimadzu Medical Systems II Apr-28-2016
16 Toshiba American Medical Systems Inc II Mar-16-2011
-
-