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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interventional fluoroscopic x-ray system
Definition Interventional fluoroscopy
Product CodeOWB
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIRCINUS MEDICAL TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONTROLRAD, INC
  SUBSTANTIALLY EQUIVALENT 2
CONTROLRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CYDAR LTD.
  SUBSTANTIALLY EQUIVALENT 1
ECENTIAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 2
ECOTRON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GENORAY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
IMAGEXRAY, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDPHOTON GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRONICA SRL
  SUBSTANTIALLY EQUIVALENT 1
MX IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
NRT X-RAY A/S
  SUBSTANTIALLY EQUIVALENT 1
NVIEW MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NVIEW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS INDIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PORTAVISION MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 3
RADIACTION LTD.
  SUBSTANTIALLY EQUIVALENT 2
SG HEALTHCARE CO LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 13
SIEMENS MEDICAL SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SYSTEMS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
STEPHANIX
  SUBSTANTIALLY EQUIVALENT 2
SURGIVISIO
  SUBSTANTIALLY EQUIVALENT 1
THERENVA SAS
  SUBSTANTIALLY EQUIVALENT 2
TRACK X TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRACKX TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XORAN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 1449 1449
2019 1558 1558
2020 1581 1581
2021 1981 1981
2022 2934 2934
2023 2573 2573

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 2844 2844
Radiation Output Failure 1517 1517
Activation Failure 1400 1400
Positioning Problem 914 914
Communication or Transmission Problem 594 594
Use of Device Problem 487 487
Noise, Audible 469 469
Positioning Failure 436 436
Device Operates Differently Than Expected 413 413
No Display/Image 402 402
Device Sensing Problem 386 386
Poor Quality Image 368 368
Failure to Power Up 335 335
Failure to Run on Battery 257 257
Electrical /Electronic Property Problem 222 222
Imprecision 213 213
Adverse Event Without Identified Device or Use Problem 195 195
Unexpected Shutdown 177 177
Material Deformation 167 167
Image Display Error/Artifact 167 167
Device Displays Incorrect Message 153 153
Failure to Charge 148 148
Physical Resistance/Sticking 144 144
Mechanical Problem 142 142
Insufficient Information 131 131
Output Problem 118 118
Unintended Movement 113 113
Power Problem 106 106
Calibration Problem 91 91
Wireless Communication Problem 82 82
No Device Output 79 79
Difficult to Open or Close 72 72
Detachment of Device or Device Component 61 61
Computer Software Problem 53 53
Radiation Output Problem 51 51
Smoking 47 47
Display or Visual Feedback Problem 46 46
Device Operational Issue 41 41
Failure to Shut Off 39 39
Device Inoperable 37 37
Device Damaged Prior to Use 35 35
No Apparent Adverse Event 34 34
Data Problem 32 32
Application Interface Becomes Non-Functional Or Program Exits Abnormally 32 32
Device Stops Intermittently 31 31
Mechanical Jam 31 31
Unintended System Motion 28 28
Break 27 27
Overheating of Device 26 26
Unintended Collision 26 26
Erratic or Intermittent Display 24 24
Loose or Intermittent Connection 23 23
Connection Problem 23 23
Computer Operating System Problem 21 21
Arcing 21 21
Application Program Problem 19 19
Radiation Overexposure 18 18
Device Fell 18 18
Unexpected/Unintended Radiation Output 18 18
Therapeutic or Diagnostic Output Failure 16 16
Difficult or Delayed Activation 16 16
Failure to Obtain Sample 14 14
Unintended Electrical Shock 14 14
Operating System Becomes Nonfunctional 13 13
Failure to Advance 12 12
Improper or Incorrect Procedure or Method 12 12
Loss of Power 11 11
Defective Component 11 11
Defective Device 10 10
Temperature Problem 10 10
Intermittent Loss of Power 10 10
Appropriate Term/Code Not Available 9 9
Material Integrity Problem 9 9
Component Missing 9 9
Malposition of Device 9 9
Fire 9 9
Bent 8 8
Unstable 8 8
Device Slipped 8 8
No Flow 8 8
Human-Device Interface Problem 7 7
Device Dislodged or Dislocated 7 7
Device Handling Problem 7 7
Intermittent Communication Failure 6 6
Patient Data Problem 6 6
Complete Loss of Power 6 6
Installation-Related Problem 6 6
Material Twisted/Bent 6 6
Optical Problem 6 6
Problem with Software Installation 6 6
Protective Measures Problem 6 6
Device Emits Odor 6 6
Difficult or Delayed Positioning 6 6
Leak/Splash 6 6
Entrapment of Device 5 5
Premature Discharge of Battery 5 5
Structural Problem 5 5
Key or Button Unresponsive/not Working 5 5
Sparking 4 4
Circuit Failure 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7663 7663
No Patient Involvement 2371 2371
No Known Impact Or Consequence To Patient 1663 1663
No Consequences Or Impact To Patient 176 176
Insufficient Information 77 77
Radiation Exposure, Unintended 44 44
Injury 32 32
Death 29 29
Unintended Radiation Exposure 26 26
Unspecified Tissue Injury 21 21
Hair Loss 15 15
Laceration(s) 14 14
Tissue Damage 14 14
Cardiac Arrest 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Fall 11 11
Patient Problem/Medical Problem 11 11
Bone Fracture(s) 11 11
Bruise/Contusion 10 10
Pain 10 10
Crushing Injury 9 9
Electric Shock 7 7
No Code Available 7 7
Radiation Overdose 7 7
Radiation Burn 5 5
Iatrogenic Source 5 5
Head Injury 4 4
Burn(s) 4 4
Abrasion 4 4
Embolism/Embolus 3 3
Sudden Cardiac Death 3 3
No Information 3 3
Myocardial Infarction 3 3
Hemorrhage/Bleeding 2 2
Hematoma 2 2
Skin Inflammation 2 2
Headache 2 2
Unspecified Infection 2 2
Suture Abrasion 2 2
Cardiopulmonary Arrest 2 2
Numbness 2 2
Underdose 2 2
Superficial (First Degree) Burn 2 2
Concussion 2 2
Muscle/Tendon Damage 2 2
Vascular Dissection 2 2
Paresthesia 2 2
Failure of Implant 2 2
Muscle Weakness 2 2
Ruptured Aneurysm 2 2
Dysphasia 2 2
Convulsion/Seizure 2 2
Paresis 2 2
Radiodermatitis 2 2
Contusion 2 2
Irritability 1 1
Respiratory Arrest 1 1
Visual Impairment 1 1
Twitching 1 1
Loss of Range of Motion 1 1
Physical Entrapment 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Thrombosis/Thrombus 1 1
Infection, Indirect 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Dyskinesia 1 1
Cardiac Perforation 1 1
Unspecified Musculoskeletal problem 1 1
Full thickness (Third Degree) Burn 1 1
Spinal Column Injury 1 1
Perforation of Vessels 1 1
Deformity/ Disfigurement 1 1
Coma 1 1
Emotional Changes 1 1
Hearing Impairment 1 1
Heart Failure/Congestive Heart Failure 1 1
Cognitive Changes 1 1
Cancer 1 1
Unspecified Vascular Problem 1 1
Aneurysm 1 1
Erythema 1 1
High Blood Pressure/ Hypertension 1 1
Memory Loss/Impairment 1 1
Neuropathy 1 1
Perforation 1 1
Staphylococcus Aureus 1 1
Skin Irritation 1 1
Sprain 1 1
Shaking/Tremors 1 1
Blood Loss 1 1
Nerve Damage 1 1
Paralysis 1 1
Dizziness 1 1
Chest Pain 1 1
Unspecified Heart Problem 1 1
Dyspnea 1 1
Missing Value Reason 1 1
Unspecified Nervous System Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Barco N.V. II Nov-30-2018
2 Canon Medical System, USA, INC. II Sep-02-2022
3 Canon Medical System, USA, INC. II Jun-24-2022
4 Canon Medical System, USA, INC. II Jan-12-2022
5 Canon Medical System, USA, INC. II Mar-17-2021
6 Canon Medical System, USA, INC. II Mar-09-2021
7 Canon Medical System, USA, INC. II Dec-03-2020
8 Canon Medical System, USA, INC. II Aug-25-2020
9 Canon Medical System, USA, INC. II Jun-09-2020
10 GE Healthcare, LLC II Jun-15-2021
11 GE Medical Systems, SCS II Oct-05-2018
12 GE OEC Medical Systems, Inc II Jul-29-2021
13 Medtronic Navigation, Inc.-Littleton II Dec-31-2019
14 Medtronic Navigation, Inc.-Littleton II Nov-07-2018
15 Medtronic Navigation, Inc.-Littleton II Mar-08-2018
16 NRT X-RAY A/S II Jan-25-2022
17 PHILIPS HOME HEALTHCARE SOLUTION II Jan-28-2021
18 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Apr-20-2023
19 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-03-2022
20 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-17-2022
21 Philips Electronics North America Corporation II Sep-21-2018
22 Philips Electronics North America Corporation II May-01-2018
23 Philips Electronics North America Corporation II Feb-24-2018
24 Philips Electronics North America Corporation II Feb-24-2018
25 Philips Healthcare II Apr-05-2022
26 Philips Healthcare II Mar-23-2022
27 Philips Healthcare II Nov-24-2021
28 Philips Healthcare II Nov-24-2021
29 Philips Healthcare II Jul-25-2018
30 Philips Medical Systems Nederlands II Jun-21-2021
31 Philips Medical Systems Nederlands II Jul-30-2019
32 Philips Medical Systems Nederlands II Jun-27-2018
33 Philips North America, LLC II Sep-30-2020
34 Philips North America, LLC II May-08-2020
35 Philips North America, LLC II Apr-29-2020
36 Philips North America, LLC II Mar-13-2020
37 Philips North America, LLC II Feb-10-2020
38 Philips North America, LLC II Aug-06-2019
39 Philips North America, LLC II Mar-23-2019
40 Philips North America Llc II Apr-28-2023
41 Philips North America Llc II Mar-04-2022
42 Philips North America Llc II Jan-10-2022
43 Philips North America Llc II Jan-10-2022
44 Philips North America Llc II Dec-22-2021
45 Philips North America Llc II Dec-09-2021
46 Philips North America Llc II Sep-14-2021
47 Shimadzu Medical Systems II Feb-28-2022
48 Shimadzu Medical Systems II Dec-10-2020
49 Shimadzu Medical Systems II Jul-14-2020
50 Shimadzu Medical Systems Usa Com II Feb-21-2019
51 Shimadzu Medical Systems Usa Com II Oct-19-2018
52 Siemens Medical Solutions USA, INC II Feb-14-2018
53 Siemens Medical Solutions USA, Inc II May-23-2023
54 Siemens Medical Solutions USA, Inc II May-02-2023
55 Siemens Medical Solutions USA, Inc II Apr-27-2023
56 Siemens Medical Solutions USA, Inc II Mar-30-2023
57 Siemens Medical Solutions USA, Inc II Feb-23-2023
58 Siemens Medical Solutions USA, Inc II Jan-30-2023
59 Siemens Medical Solutions USA, Inc II Jan-20-2023
60 Siemens Medical Solutions USA, Inc II Jan-13-2023
61 Siemens Medical Solutions USA, Inc II Aug-26-2022
62 Siemens Medical Solutions USA, Inc II Jul-07-2022
63 Siemens Medical Solutions USA, Inc II Jul-06-2022
64 Siemens Medical Solutions USA, Inc II Jun-07-2022
65 Siemens Medical Solutions USA, Inc II Apr-21-2022
66 Siemens Medical Solutions USA, Inc II Apr-21-2022
67 Siemens Medical Solutions USA, Inc II Jan-21-2022
68 Siemens Medical Solutions USA, Inc II Nov-24-2021
69 Siemens Medical Solutions USA, Inc II Nov-04-2021
70 Siemens Medical Solutions USA, Inc II Sep-02-2021
71 Siemens Medical Solutions USA, Inc II Jul-07-2021
72 Siemens Medical Solutions USA, Inc II Jun-02-2021
73 Siemens Medical Solutions USA, Inc II May-13-2021
74 Siemens Medical Solutions USA, Inc II Apr-26-2021
75 Siemens Medical Solutions USA, Inc II Apr-26-2021
76 Siemens Medical Solutions USA, Inc II Mar-22-2021
77 Siemens Medical Solutions USA, Inc II Feb-23-2021
78 Siemens Medical Solutions USA, Inc II Jan-11-2021
79 Siemens Medical Solutions USA, Inc II Nov-18-2020
80 Siemens Medical Solutions USA, Inc II Nov-04-2020
81 Siemens Medical Solutions USA, Inc II Oct-27-2020
82 Siemens Medical Solutions USA, Inc II Oct-15-2020
83 Siemens Medical Solutions USA, Inc II Aug-26-2020
84 Siemens Medical Solutions USA, Inc II Aug-22-2020
85 Siemens Medical Solutions USA, Inc II Jun-09-2020
86 Siemens Medical Solutions USA, Inc II Jun-03-2020
87 Siemens Medical Solutions USA, Inc II May-22-2020
88 Siemens Medical Solutions USA, Inc II May-04-2020
89 Siemens Medical Solutions USA, Inc II May-04-2020
90 Siemens Medical Solutions USA, Inc II Mar-13-2020
91 Siemens Medical Solutions USA, Inc II Feb-20-2020
92 Siemens Medical Solutions USA, Inc II Feb-20-2020
93 Siemens Medical Solutions USA, Inc II Feb-20-2020
94 Siemens Medical Solutions USA, Inc II Jan-13-2020
95 Siemens Medical Solutions USA, Inc II Jan-07-2020
96 Siemens Medical Solutions USA, Inc II Dec-17-2019
97 Siemens Medical Solutions USA, Inc II Aug-24-2019
98 Siemens Medical Solutions USA, Inc II Jul-22-2019
99 Siemens Medical Solutions USA, Inc II Jul-09-2019
100 Siemens Medical Solutions USA, Inc II Jun-28-2019
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