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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
ACREW IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ECENTIAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 2
ECOTRON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 1
GEMSS HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
NDR MEDICAL TECHNOLOGY PTE. LTD.
  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 5

MDR Year MDR Reports MDR Events
2018 1449 1449
2019 1558 1558
2020 1581 1581
2021 1981 1981
2022 2933 2933
2023 6968 6968

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 3257 3257
Activation Failure 3028 3028
Radiation Output Failure 2795 2795
Positioning Problem 1032 1032
Positioning Failure 879 879
Communication or Transmission Problem 638 638
No Display/Image 623 623
Noise, Audible 527 527
Use of Device Problem 522 522
Device Sensing Problem 452 452
Poor Quality Image 435 435
Device Operates Differently Than Expected 413 413
Failure to Power Up 361 361
Failure to Run on Battery 258 258
Imprecision 230 230
Electrical /Electronic Property Problem 224 224
Unexpected Shutdown 217 217
Adverse Event Without Identified Device or Use Problem 213 213
Image Display Error/Artifact 198 198
Material Deformation 184 184
Mechanical Problem 168 168
Physical Resistance/Sticking 156 156
Output Problem 153 153
Device Displays Incorrect Message 153 153
Failure to Charge 150 150
Insufficient Information 147 147
Unintended Movement 131 131
Power Problem 113 113
Detachment of Device or Device Component 107 107
Calibration Problem 101 101
Failure to Advance 92 92
Wireless Communication Problem 89 89
No Device Output 87 87
Radiation Output Problem 74 74
Difficult to Open or Close 72 72
Application Program Problem 62 62
Computer Software Problem 62 62
Smoking 59 59
Display or Visual Feedback Problem 58 58
Unintended System Motion 53 53
Device Operational Issue 41 41
Failure to Shut Off 40 40
Erratic or Intermittent Display 40 40
Device Damaged Prior to Use 38 38
Device Inoperable 37 37
Unintended Collision 37 37
No Apparent Adverse Event 37 37
Data Problem 33 33
Mechanical Jam 33 33
Application Interface Becomes Non-Functional Or Program Exits Abnormally 32 32
Device Stops Intermittently 31 31
Break 30 30
Loose or Intermittent Connection 27 27
Overheating of Device 26 26
Connection Problem 25 25
Arcing 24 24
Computer Operating System Problem 23 23
Radiation Overexposure 22 22
Unexpected/Unintended Radiation Output 22 22
Device Fell 21 21
Difficult or Delayed Activation 20 20
Unintended Electrical Shock 18 18
Therapeutic or Diagnostic Output Failure 17 17
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Operating System Becomes Nonfunctional 15 15
Failure to Obtain Sample 14 14
Defective Component 14 14
Improper or Incorrect Procedure or Method 14 14
Loss of Power 13 13
Intermittent Loss of Power 13 13
Component Missing 12 12
Unstable 11 11
Fire 11 11
Difficult or Delayed Positioning 11 11
Temperature Problem 11 11
Appropriate Term/Code Not Available 11 11
Complete Loss of Power 10 10
Defective Device 10 10
Malposition of Device 9 9
Material Integrity Problem 9 9
Device Dislodged or Dislocated 9 9
Failure to Transmit Record 9 9
Device Slipped 8 8
Bent 8 8
No Flow 8 8
Patient Data Problem 8 8
Device Handling Problem 8 8
Problem with Software Installation 8 8
Intermittent Communication Failure 7 7
Installation-Related Problem 7 7
Human-Device Interface Problem 7 7
Activation, Positioning or Separation Problem 6 6
Material Twisted/Bent 6 6
Optical Problem 6 6
Sparking 6 6
Leak/Splash 6 6
Display Difficult to Read 6 6
Device Emits Odor 6 6
Key or Button Unresponsive/not Working 6 6
Protective Measures Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11991 11991
No Patient Involvement 2371 2371
No Known Impact Or Consequence To Patient 1663 1663
No Consequences Or Impact To Patient 176 176
Insufficient Information 126 126
Radiation Exposure, Unintended 44 44
Injury 32 32
Death 29 29
Unintended Radiation Exposure 27 27
Unspecified Tissue Injury 23 23
Hair Loss 22 22
Laceration(s) 17 17
Bone Fracture(s) 16 16
Cardiac Arrest 14 14
Tissue Damage 14 14
Pain 12 12
Bruise/Contusion 12 12
Fall 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Patient Problem/Medical Problem 11 11
Crushing Injury 8 8
Radiation Overdose 7 7
Electric Shock 7 7
No Code Available 7 7
Iatrogenic Source 5 5
Abrasion 5 5
Radiation Burn 5 5
Burn(s) 4 4
Head Injury 4 4
Myocardial Infarction 4 4
Muscle Weakness 3 3
Failure of Implant 3 3
Hemorrhage/Bleeding 3 3
Sudden Cardiac Death 3 3
No Information 3 3
Ruptured Aneurysm 3 3
Embolism/Embolus 3 3
Paresthesia 2 2
Convulsion/Seizure 2 2
Muscle/Tendon Damage 2 2
Unspecified Vascular Problem 2 2
Vascular Dissection 2 2
Superficial (First Degree) Burn 2 2
Underdose 2 2
Unspecified Infection 2 2
Headache 2 2
Hematoma 2 2
Contusion 2 2
Aneurysm 2 2
Cardiopulmonary Arrest 2 2
Dysphasia 2 2
Radiodermatitis 2 2
Coma 2 2
Obstruction/Occlusion 2 2
Skin Inflammation 2 2
Suture Abrasion 2 2
Concussion 2 2
Paralysis 2 2
Paresis 2 2
Perforation 2 2
Pneumothorax 1 1
Loss of Range of Motion 1 1
Staphylococcus Aureus 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Sprain 1 1
Dizziness 1 1
Nerve Damage 1 1
Neuropathy 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Twitching 1 1
Irritability 1 1
Deformity/ Disfigurement 1 1
Dyskinesia 1 1
Numbness 1 1
Therapeutic Response, Decreased 1 1
Physical Entrapment 1 1
Anxiety 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Infection, Indirect 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Apnea 1 1
Bacterial Infection 1 1
Dyspnea 1 1
Emotional Changes 1 1
Erythema 1 1
Perinatal Brain Injury 1 1
Hearing Impairment 1 1
Damage to Ligament(s) 1 1
Memory Loss/Impairment 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
High Blood Pressure/ Hypertension 1 1
Cognitive Changes 1 1
Blood Loss 1 1

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