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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, x-ray, angiographic
Regulation Description Angiographic x-ray system.
Product CodeIZI
Regulation Number 892.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
LEICA MICROSYSTEMS (SCHWEIZ) AG
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
NOVADAQ TECHNOLOGIES ULC. (NOW A PART OF STRYKER)
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ONLUME INC.
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING BV
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 88 88
2018 49 49
2019 30 30
2020 14 14
2021 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 50 50
Radiation Output Failure 12 12
Device Operates Differently Than Expected 12 12
No Display/Image 12 12
Device Displays Incorrect Message 11 11
No Apparent Adverse Event 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Smoking 7 7
Use of Device Problem 6 6
Radiation Overexposure 6 6
Unintended Movement 5 5
Overheating of Device 5 5
Break 4 4
Fire 4 4
Poor Quality Image 4 4
Detachment of Device or Device Component 4 4
Positioning Problem 4 4
Missing Value Reason 4 4
Defective Device 4 4
Device Operational Issue 3 3
Physical Resistance/Sticking 3 3
Device Fell 3 3
Fluid Leak 3 3
Positioning Failure 3 3
Loss of Power 3 3
Failure to Power Up 3 3
Device Inoperable 3 3
Failure to Read Input Signal 2 2
Defective Component 2 2
Entrapment of Device 2 2
Computer Software Problem 2 2
Thermal Decomposition of Device 2 2
Image Display Error/Artifact 2 2
Unexpected Shutdown 2 2
Noise, Audible 2 2
Operating System Becomes Nonfunctional 2 2
Computer Operating System Problem 2 2
Data Back-Up Problem 2 2
Device Tipped Over 1 1
Sparking 1 1
Application Program Problem 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Device Dislodged or Dislocated 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Output Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Image Resolution Poor 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
Output above Specifications 1 1
No Device Output 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Contamination 1 1
Crack 1 1
Disconnection 1 1
Difficult To Position 1 1
Repair 1 1
Failure to Reset 1 1
Component Missing 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Inaccurate Synchronization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 86 86
No Consequences Or Impact To Patient 34 34
No Clinical Signs, Symptoms or Conditions 25 25
No Information 9 9
No Code Available 8 8
Death 7 7
Burn(s) 6 6
Injury 6 6
No Patient Involvement 4 4
Radiation Overdose 4 4
Hair Loss 4 4
Laceration(s) 3 3
Bruise/Contusion 3 3
Insufficient Information 3 3
Radiation Exposure, Unintended 3 3
Crushing Injury 2 2
Electric Shock 2 2
Not Applicable 1 1
Reaction 1 1
Skin Tears 1 1
Discharge 1 1
Complaint, Ill-Defined 1 1
Hemorrhagic Stroke 1 1
Radiation Burn 1 1
Aneurysm 1 1
Cardiac Arrest 1 1
Fall 1 1
Myocardial Infarction 1 1
Overdose 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Head Injury 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Apr-18-2019
2 Philips Electronics North America Corporation II Sep-21-2018
3 Philips Electronics North America Corporation II Jan-20-2017
4 Philips Electronics North America Corporation II Jan-20-2017
5 Philips Medical Systems Nederlands II Apr-13-2019
6 Philips Medical Systems Nederlands II May-03-2018
7 Philips North America, LLC II Mar-13-2020
8 Philips North America, LLC II Mar-23-2019
9 Shimadzu Medical Systems II Dec-10-2020
10 Shimadzu Medical Systems II Jun-14-2018
11 Shimadzu Medical Systems Usa Com II Feb-27-2019
12 Siemens Medical Solutions USA, Inc II May-15-2019
13 Siemens Medical Solutions USA, Inc II Dec-05-2018
14 Siemens Medical Solutions USA, Inc II Nov-14-2018
15 Siemens Medical Solutions USA, Inc II Feb-23-2018
16 Siemens Medical Solutions USA, Inc II Aug-29-2017
17 Siemens Medical Solutions USA, Inc II Jul-14-2017
18 Siemens Medical Solutions USA, Inc II Mar-30-2017
19 Siemens Medical Solutions USA, Inc II Mar-14-2017
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