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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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New Search show TPLC since Back to Search Results
Device system, x-ray, angiographic
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
SURGVISION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 88 88
2018 49 49
2019 30 30
2020 14 14
2021 29 29
2022 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 50 50
Radiation Output Failure 24 24
No Display/Image 14 14
Device Operates Differently Than Expected 12 12
Device Displays Incorrect Message 11 11
No Apparent Adverse Event 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Smoking 10 10
Unintended System Motion 9 9
Use of Device Problem 6 6
Detachment of Device or Device Component 6 6
Radiation Overexposure 6 6
Unintended Movement 6 6
Overheating of Device 5 5
Poor Quality Image 5 5
Positioning Failure 5 5
Break 4 4
Fire 4 4
Missing Value Reason 4 4
Physical Resistance/Sticking 4 4
Positioning Problem 4 4
Defective Device 4 4
Device Operational Issue 3 3
Device Fell 3 3
Fluid Leak 3 3
Entrapment of Device 3 3
Device Inoperable 3 3
Loss of Power 3 3
Failure to Power Up 3 3
Failure to Read Input Signal 2 2
Image Display Error/Artifact 2 2
Thermal Decomposition of Device 2 2
Computer Software Problem 2 2
Unexpected Shutdown 2 2
Operating System Becomes Nonfunctional 2 2
Output Problem 2 2
Computer Operating System Problem 2 2
Data Back-Up Problem 2 2
Device Dislodged or Dislocated 2 2
Defective Component 2 2
Noise, Audible 2 2
Component Missing 1 1
Device Tipped Over 1 1
Sparking 1 1
Application Program Problem 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 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
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Data Problem 1 1
Contamination 1 1
Crack 1 1
Disconnection 1 1
Detachment Of Device Component 1 1
Component Falling 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
Other (for use when an appropriate device code cannot be identified) 1 1
Difficult To Position 1 1
Inaccurate Synchronization 1 1
Repair 1 1
Failure to Reset 1 1
Energy Output Problem 1 1
Output above Specifications 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 86 86
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 34 34
No Information 9 9
Insufficient Information 9 9
No Code Available 8 8
Death 7 7
Burn(s) 6 6
Laceration(s) 6 6
Injury 6 6
Fall 5 5
Radiation Overdose 4 4
Hair Loss 4 4
No Patient Involvement 4 4
Radiation Exposure, Unintended 3 3
Crushing Injury 3 3
Pain 3 3
Bruise/Contusion 3 3
Hemorrhage/Bleeding 2 2
Electric Shock 2 2
Not Applicable 1 1
Hemorrhagic Stroke 1 1
Reaction 1 1
Obstruction/Occlusion 1 1
Skin Tears 1 1
Myocardial Infarction 1 1
Overdose 1 1
Discharge 1 1
Complaint, Ill-Defined 1 1
Hypersensitivity/Allergic reaction 1 1
Head Injury 1 1
Hematoma 1 1
Paresis 1 1
Skull Fracture 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Radiation Burn 1 1
Aneurysm 1 1
Bone Fracture(s) 1 1
Cardiac Arrest 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 Feb-28-2022
10 Shimadzu Medical Systems II Dec-10-2020
11 Shimadzu Medical Systems II Jun-14-2018
12 Shimadzu Medical Systems Usa Com II Feb-27-2019
13 Siemens Medical Solutions USA, Inc II May-15-2019
14 Siemens Medical Solutions USA, Inc II Dec-05-2018
15 Siemens Medical Solutions USA, Inc II Nov-14-2018
16 Siemens Medical Solutions USA, Inc II Feb-23-2018
17 Siemens Medical Solutions USA, Inc II Aug-29-2017
18 Siemens Medical Solutions USA, Inc II Jul-14-2017
19 Siemens Medical Solutions USA, Inc II Mar-30-2017
20 Siemens Medical Solutions USA, Inc II Mar-14-2017
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