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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, angiographic
Product CodeIZI
Regulation Number 892.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTERYFLOW TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS SURGICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
HAMAMATSU PHOTONICS, K.K.
  SUBSTANTIALLY EQUIVALENT 1
LEICA BIOSYSTEMS RICHMOND
  SUBSTANTIALLY EQUIVALENT 1
LEICA MICROSYSTEMS (SCHWEIZ) AG
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MIVENION GMBH
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES ULC (A PART OF STRYKER)
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES ULC. (NOW A PART OF STRYKER)
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ONLUME INC.
  SUBSTANTIALLY EQUIVALENT 1
PAIEON, INC.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING B.V.
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING BV
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGVISION GMBH
  SUBSTANTIALLY EQUIVALENT 3
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNC-RX LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 123 123
2015 37 37
2016 102 102
2017 88 88
2018 49 49
2019 30 30
2020 14 14
2021 29 29
2022 264 264
2023 1198 1198
2024 512 512

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 850 850
Radiation Output Failure 639 639
Positioning Failure 269 269
No Display/Image 165 165
Device Operates Differently Than Expected 90 90
Insufficient Information 61 61
Device Inoperable 34 34
Bent 30 30
Device Displays Incorrect Message 25 25
Failure to Power Up 24 24
Loss of Power 20 20
Smoking 20 20
Unintended System Motion 20 20
Detachment of Device or Device Component 19 19
Adverse Event Without Identified Device or Use Problem 19 19
Device Stops Intermittently 14 14
No Device Output 13 13
Erratic or Intermittent Display 12 12
Computer Operating System Problem 12 12
No Apparent Adverse Event 11 11
Break 11 11
Overheating of Device 11 11
Difficult or Delayed Activation 10 10
Image Display Error/Artifact 10 10
Poor Quality Image 10 10
Unintended Movement 10 10
Unexpected Shutdown 9 9
Output Problem 9 9
Radiation Overexposure 9 9
Mechanical Problem 9 9
Fire 8 8
Component Falling 8 8
Use of Device Problem 7 7
Sticking 7 7
Defective Device 6 6
Detachment Of Device Component 6 6
Display or Visual Feedback Problem 6 6
Fluid/Blood Leak 5 5
Positioning Problem 5 5
Power Problem 5 5
Noise, Audible 5 5
Physical Resistance/Sticking 4 4
Appropriate Term/Code Not Available 4 4
Missing Value Reason 4 4
Mechanical Jam 4 4
Loose or Intermittent Connection 4 4
Application Interface Becomes Non-Functional Or Program Exits Abnormally 4 4
Defective Component 4 4
Self-Activation or Keying 4 4
Device Emits Odor 4 4
Output above Specifications 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Advance 3 3
Difficult or Delayed Positioning 3 3
Computer Software Problem 3 3
Entrapment of Device 3 3
Communication or Transmission Problem 3 3
Radiation Underexposure 3 3
Data Back-Up Problem 3 3
Device Operational Issue 3 3
Device Dislodged or Dislocated 3 3
Data Problem 3 3
Naturally Worn 3 3
Temperature Problem 3 3
Device Fell 3 3
Radiation Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unexpected/Unintended Radiation Output 2 2
Air/Gas in Device 2 2
Human-Device Interface Problem 2 2
Inappropriate or Unexpected Reset 2 2
Loss of Data 2 2
Application Program Problem 2 2
Operating System Becomes Nonfunctional 2 2
Device Alarm System 2 2
Thermal Decomposition of Device 2 2
Partial Blockage 2 2
Intermittent Continuity 2 2
Failure to Read Input Signal 2 2
Failure to Reset 2 2
Inaccurate Synchronization 1 1
Failure to Transmit Record 1 1
Repair 1 1
Difficult To Position 1 1
Power Conditioning Problem 1 1
Separation Failure 1 1
Unstable 1 1
Device Tipped Over 1 1
Arcing 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Visual Prompts will not Clear 1 1
Component Missing 1 1
Device Issue 1 1
Structural Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Electrical /Electronic Property Problem 1 1
Emergency Power Failure 1 1
Contamination 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1968 1968
No Known Impact Or Consequence To Patient 231 231
No Consequences Or Impact To Patient 59 59
Insufficient Information 30 30
No Information 27 27
Death 20 20
No Patient Involvement 19 19
No Code Available 17 17
Injury 16 16
Burn(s) 12 12
Hair Loss 10 10
Fall 9 9
Radiation Overdose 8 8
Laceration(s) 7 7
Radiation Burn 6 6
Bruise/Contusion 4 4
Cardiac Arrest 4 4
Pain 4 4
Radiation Exposure, Unintended 4 4
Myocardial Infarction 3 3
Crushing Injury 3 3
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 2 2
Bone Fracture(s) 2 2
Tissue Damage 2 2
Hematoma 2 2
Complaint, Ill-Defined 2 2
Electric Shock 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemorrhagic Stroke 1 1
Ruptured Aneurysm 1 1
Chemical Exposure 1 1
Not Applicable 1 1
Vascular Dissection 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Paresis 1 1
Skull Fracture 1 1
Nausea 1 1
Occlusion 1 1
Overdose 1 1
Reaction 1 1
Obstruction/Occlusion 1 1
Skin Tears 1 1
Heart Failure 1 1
Brain Injury 1 1
Discharge 1 1
Pressure Sores 1 1
Discomfort 1 1
Head Injury 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Aneurysm 1 1
Bradycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Jul-03-2015
2 GE Healthcare, LLC II Apr-18-2019
3 GE Healthcare, LLC II Dec-23-2016
4 GE Healthcare, LLC II Dec-16-2014
5 GE Healthcare, LLC II Jan-28-2014
6 GE Healthcare, LLC II Oct-17-2012
7 GE Healthcare, LLC II Mar-19-2012
8 GE Medical Systems, LLC II Dec-12-2015
9 GE Medical Systems, LLC II Nov-09-2009
10 NOVADAQ TECHNOLOGIES INC. II Sep-08-2016
11 NeuroLogica Corporation II Nov-10-2015
12 Novadaq Technologies, Inc. III Dec-01-2014
13 Philips Electronics North America Corporation II Sep-21-2018
14 Philips Electronics North America Corporation II Jan-20-2017
15 Philips Electronics North America Corporation II Jan-20-2017
16 Philips Electronics North America Corporation II Aug-01-2016
17 Philips Electronics North America Corporation II Feb-16-2016
18 Philips Electronics North America Corporation II Jan-30-2016
19 Philips Healthcare Inc. II Jun-20-2012
20 Philips Healthcare Inc. II Apr-25-2012
21 Philips Healthcare Inc. II Mar-29-2012
22 Philips Healthcare Inc. II Feb-08-2012
23 Philips Healthcare Inc. II Feb-02-2012
24 Philips Healthcare Inc. II Aug-10-2011
25 Philips Medical Systems Nederlands II Apr-13-2019
26 Philips Medical Systems Nederlands II May-03-2018
27 Philips Medical Systems Nederlands II Mar-09-2012
28 Philips Medical Systems North America Co. Phillips II Mar-22-2011
29 Philips Medical Systems North America Co. Phillips II Mar-16-2011
30 Philips Medical Systems North America Co. Phillips II Jan-18-2011
31 Philips Medical Systems North America Co. Phillips II Dec-07-2010
32 Philips Medical Systems North America Co. Phillips II Oct-22-2010
33 Philips Medical Systems North America Co. Phillips II Sep-22-2010
34 Philips Medical Systems North America Co. Phillips II Sep-22-2010
35 Philips Medical Systems North America Co. Phillips II Aug-11-2010
36 Philips Medical Systems North America Co. Phillips II Sep-24-2009
37 Philips Medical Systems, Inc. II Mar-31-2016
38 Philips Medical Systems, Inc. II Mar-02-2015
39 Philips Medical Systems, Inc. II Feb-26-2015
40 Philips North America, LLC II Mar-13-2020
41 Philips North America, LLC II Mar-23-2019
42 Shimadzu Medical Systems II Feb-28-2022
43 Shimadzu Medical Systems II Dec-10-2020
44 Shimadzu Medical Systems II Jun-14-2018
45 Shimadzu Medical Systems II May-08-2014
46 Shimadzu Medical Systems Usa Com II Feb-27-2019
47 Siemens Medical Solutions USA, Inc II May-15-2019
48 Siemens Medical Solutions USA, Inc II Dec-05-2018
49 Siemens Medical Solutions USA, Inc II Nov-14-2018
50 Siemens Medical Solutions USA, Inc II Feb-23-2018
51 Siemens Medical Solutions USA, Inc II Aug-29-2017
52 Siemens Medical Solutions USA, Inc II Jul-14-2017
53 Siemens Medical Solutions USA, Inc II Mar-30-2017
54 Siemens Medical Solutions USA, Inc II Mar-14-2017
55 Siemens Medical Solutions USA, Inc II Aug-11-2016
56 Siemens Medical Solutions USA, Inc II Aug-05-2016
57 Siemens Medical Solutions USA, Inc II Mar-31-2016
58 Siemens Medical Solutions USA, Inc II Mar-31-2016
59 Siemens Medical Solutions USA, Inc II Mar-31-2016
60 Siemens Medical Solutions USA, Inc II Aug-05-2015
61 Siemens Medical Solutions USA, Inc II Jan-14-2015
62 Siemens Medical Solutions USA, Inc II Dec-01-2014
63 Siemens Medical Solutions USA, Inc II Nov-07-2014
64 Siemens Medical Solutions USA, Inc II Sep-24-2014
65 Siemens Medical Solutions USA, Inc II Sep-22-2014
66 Siemens Medical Solutions USA, Inc II Mar-31-2014
67 Siemens Medical Solutions USA, Inc II Mar-22-2014
68 Siemens Medical Solutions USA, Inc II Feb-24-2014
69 Siemens Medical Solutions USA, Inc II Nov-14-2013
70 Siemens Medical Solutions USA, Inc II Aug-28-2013
71 Siemens Medical Solutions USA, Inc II Aug-09-2013
72 Siemens Medical Solutions USA, Inc II Jul-22-2013
73 Siemens Medical Solutions USA, Inc II Jul-17-2013
74 Siemens Medical Solutions USA, Inc II Mar-26-2013
75 Siemens Medical Solutions USA, Inc II Mar-25-2013
76 Siemens Medical Solutions USA, Inc II Oct-26-2010
77 Siemens Medical Solutions USA, Inc II Aug-16-2010
78 Siemens Medical Solutions USA, Inc II Apr-08-2010
79 Siemens Medical Solutions USA, Inc II Dec-03-2009
80 Siemens Medical Solutions USA, Inc II Nov-10-2009
81 Siemens Medical Solutions USA, Inc II Jun-16-2009
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