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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 B.V.
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING BV
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 102 102
2017 88 88
2018 49 49
2019 30 30
2020 14 14
2021 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 51 51
Insufficient Information 50 50
No Display/Image 18 18
Device Displays Incorrect Message 16 16
Device Inoperable 13 13
Smoking 11 11
Adverse Event Without Identified Device or Use Problem 11 11
No Apparent Adverse Event 11 11
Overheating of Device 10 10
Loss of Power 9 9
Break 8 8
Fire 7 7
Computer Operating System Problem 7 7
Unintended Movement 7 7
Radiation Overexposure 7 7
Radiation Output Failure 7 7
Use of Device Problem 6 6
Failure to Power Up 6 6
Mechanical Problem 6 6
Poor Quality Image 5 5
Defective Device 5 5
Detachment of Device or Device Component 5 5
Positioning Problem 4 4
Missing Value Reason 4 4
Fluid Leak 4 4
Image Display Error/Artifact 3 3
Positioning Failure 3 3
Detachment Of Device Component 3 3
Component Falling 3 3
Device Emits Odor 3 3
Self-Activation or Keying 3 3
Data Back-Up Problem 3 3
Device Operational Issue 3 3
Noise, Audible 3 3
Physical Resistance/Sticking 3 3
Device Fell 3 3
Unexpected Shutdown 2 2
Appropriate Term/Code Not Available 2 2
Operating System Becomes Nonfunctional 2 2
Application Program Problem 2 2
Failure to Reset 2 2
Communication or Transmission Problem 2 2
Defective Component 2 2
Sticking 2 2
Device Stops Intermittently 2 2
Failure to Read Input Signal 2 2
Unintended System Motion 2 2
Partial Blockage 2 2
Entrapment of Device 2 2
Computer Software Problem 2 2
Thermal Decomposition of Device 2 2
Device Alarm System 2 2
Bent 1 1
Contamination 1 1
Crack 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Image Resolution Poor 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Output above Specifications 1 1
No Device Output 1 1
Difficult To Position 1 1
Power Conditioning Problem 1 1
Failure to Transmit Record 1 1
Repair 1 1
Inaccurate Synchronization 1 1
Improper or Incorrect Procedure or Method 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Component Missing 1 1
Device Issue 1 1
Failure to Advance 1 1
Arcing 1 1
Device Tipped Over 1 1
Sparking 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Output Problem 1 1
Loss of Data 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
Inappropriate or Unexpected Reset 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Power Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Data Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 150 150
No Consequences Or Impact To Patient 41 41
No Clinical Signs, Symptoms or Conditions 19 19
No Patient Involvement 14 14
No Information 14 14
No Code Available 12 12
Death 9 9
Injury 8 8
Burn(s) 6 6
Radiation Overdose 6 6
Hair Loss 4 4
Laceration(s) 4 4
Radiation Exposure, Unintended 4 4
Insufficient Information 3 3
Bruise/Contusion 3 3
Cardiac Arrest 3 3
Crushing Injury 2 2
Radiation Burn 2 2
Electric Shock 2 2
Chemical Exposure 1 1
Reaction 1 1
Skin Tears 1 1
Discharge 1 1
Pressure Sores 1 1
Complaint, Ill-Defined 1 1
Not Applicable 1 1
Hemorrhagic Stroke 1 1
Aneurysm 1 1
Bradycardia 1 1
Fall 1 1
Myocardial Infarction 1 1
Nausea 1 1
Occlusion 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
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Apr-18-2019
2 GE Healthcare, LLC II Dec-23-2016
3 NOVADAQ TECHNOLOGIES INC. II Sep-08-2016
4 Philips Electronics North America Corporation II Sep-21-2018
5 Philips Electronics North America Corporation II Jan-20-2017
6 Philips Electronics North America Corporation II Jan-20-2017
7 Philips Electronics North America Corporation II Aug-01-2016
8 Philips Electronics North America Corporation II Feb-16-2016
9 Philips Electronics North America Corporation II Jan-30-2016
10 Philips Medical Systems Nederlands II Apr-13-2019
11 Philips Medical Systems Nederlands II May-03-2018
12 Philips Medical Systems, Inc. II Mar-31-2016
13 Philips North America, LLC II Mar-13-2020
14 Philips North America, LLC II Mar-23-2019
15 Shimadzu Medical Systems II Dec-10-2020
16 Shimadzu Medical Systems II Jun-14-2018
17 Shimadzu Medical Systems Usa Com II Feb-27-2019
18 Siemens Medical Solutions USA, Inc II May-15-2019
19 Siemens Medical Solutions USA, Inc II Dec-05-2018
20 Siemens Medical Solutions USA, Inc II Nov-14-2018
21 Siemens Medical Solutions USA, Inc II Feb-23-2018
22 Siemens Medical Solutions USA, Inc II Aug-29-2017
23 Siemens Medical Solutions USA, Inc II Jul-14-2017
24 Siemens Medical Solutions USA, Inc II Mar-30-2017
25 Siemens Medical Solutions USA, Inc II Mar-14-2017
26 Siemens Medical Solutions USA, Inc II Aug-11-2016
27 Siemens Medical Solutions USA, Inc II Aug-05-2016
28 Siemens Medical Solutions USA, Inc II Mar-31-2016
29 Siemens Medical Solutions USA, Inc II Mar-31-2016
30 Siemens Medical Solutions USA, Inc II Mar-31-2016
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