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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 3
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
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 1
GEMSS HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
NVIEW MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NVIEW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS INDIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 1
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 1
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 13
SIEMENS MEDICAL SYSTEMS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEPHANIX
  SUBSTANTIALLY EQUIVALENT 2
SURGIVISIO
  SUBSTANTIALLY EQUIVALENT 1
THERENVA SAS
  SUBSTANTIALLY EQUIVALENT 2
TRACK X TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XORAN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 10

MDR Year MDR Reports MDR Events
2019 1558 1558
2020 1581 1581
2021 1981 1981
2022 2933 2933
2023 7611 7611
2024 2038 2038

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 3964 3964
Radiation Output Failure 3677 3677
Application Program Freezes, Becomes Nonfunctional 3286 3286
Positioning Failure 1126 1126
Positioning Problem 1007 1007
No Display/Image 721 721
Noise, Audible 541 541
Device Sensing Problem 489 489
Communication or Transmission Problem 471 471
Use of Device Problem 468 468
Poor Quality Image 443 443
Failure to Power Up 333 333
Unexpected Shutdown 248 248
Failure to Run on Battery 239 239
Image Display Error/Artifact 217 217
Adverse Event Without Identified Device or Use Problem 212 212
Imprecision 206 206
Failure to Advance 194 194
Material Deformation 161 161
Physical Resistance/Sticking 154 154
Output Problem 146 146
Mechanical Problem 142 142
Failure to Charge 140 140
Unintended Movement 131 131
Detachment of Device or Device Component 126 126
Power Problem 114 114
Radiation Output Problem 107 107
Application Program Problem 102 102
No Device Output 83 83
Unintended System Motion 75 75
Calibration Problem 70 70
Wireless Communication Problem 69 69
Electrical /Electronic Property Problem 67 67
Smoking 65 65
Insufficient Information 58 58
Display or Visual Feedback Problem 54 54
Unintended Collision 43 43
No Apparent Adverse Event 42 42
Device Operational Issue 41 41
Device Damaged Prior to Use 40 40
Failure to Shut Off 39 39
Erratic or Intermittent Display 39 39
Data Problem 35 35
Mechanical Jam 34 34
Incorrect, Inadequate or Imprecise Result or Readings 33 33
Computer Software Problem 29 29
Connection Problem 28 28
Arcing 26 26
Overheating of Device 26 26
Loose or Intermittent Connection 25 25
Unexpected/Unintended Radiation Output 24 24
Radiation Overexposure 23 23
Computer Operating System Problem 22 22
Unintended Electrical Shock 22 22
Device Fell 21 21
Difficult or Delayed Activation 21 21
Failure to Transmit Record 20 20
Therapeutic or Diagnostic Output Failure 17 17
Operating System Becomes Nonfunctional 15 15
Component Missing 14 14
Difficult or Delayed Positioning 14 14
Fire 12 12
Malposition of Device 12 12
Intermittent Loss of Power 12 12
Device Handling Problem 11 11
Complete Loss of Power 11 11
Appropriate Term/Code Not Available 11 11
Defective Component 11 11
Temperature Problem 11 11
Break 11 11
Unstable 11 11
Improper or Incorrect Procedure or Method 10 10
Loss of Power 10 10
Defective Device 10 10
Device Displays Incorrect Message 9 9
Device Dislodged or Dislocated 9 9
Material Integrity Problem 9 9
No Flow 8 8
Human-Device Interface Problem 8 8
Problem with Software Installation 8 8
Activation, Positioning or Separation Problem 8 8
Device Slipped 8 8
Patient Data Problem 8 8
Activation Problem 7 7
Key or Button Unresponsive/not Working 6 6
Display Difficult to Read 6 6
Leak/Splash 6 6
Structural Problem 6 6
Protective Measures Problem 6 6
Optical Problem 6 6
Installation-Related Problem 6 6
Entrapment of Device 5 5
Device Emits Odor 5 5
Shielding Failure 4 4
Circuit Failure 4 4
Premature Discharge of Battery 4 4
Use of Incorrect Control/Treatment Settings 4 4
Environmental Particulates 4 4
Sparking 4 4
Loss of Data 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14658 14658
No Patient Involvement 1608 1608
No Known Impact Or Consequence To Patient 1116 1116
Insufficient Information 151 151
No Consequences Or Impact To Patient 78 78
Radiation Exposure, Unintended 40 40
Unspecified Tissue Injury 27 27
Unintended Radiation Exposure 27 27
Hair Loss 22 22
Laceration(s) 17 17
Death 16 16
Injury 16 16
Bone Fracture(s) 15 15
Fall 14 14
Pain 13 13
Tissue Damage 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Bruise/Contusion 11 11
Cardiac Arrest 11 11
Patient Problem/Medical Problem 10 10
Crushing Injury 8 8
Hemorrhage/Bleeding 6 6
Head Injury 5 5
Electric Shock 5 5
No Code Available 4 4
Ruptured Aneurysm 4 4
Muscle Weakness 4 4
Myocardial Infarction 4 4
Failure of Implant 3 3
Unspecified Infection 3 3
Radiation Burn 3 3
Radiation Overdose 3 3
Abrasion 3 3
Embolism/Embolus 3 3
No Information 3 3
Full thickness (Third Degree) Burn 2 2
Superficial (First Degree) Burn 2 2
Underdose 2 2
Coma 2 2
Iatrogenic Source 2 2
Sudden Cardiac Death 2 2
Muscle/Tendon Damage 2 2
Convulsion/Seizure 2 2
Paresthesia 2 2
Unspecified Nervous System Problem 2 2
Unspecified Vascular Problem 2 2
Aneurysm 2 2
Cardiopulmonary Arrest 2 2
Burn(s) 2 2
Headache 2 2
Concussion 2 2
Perforation of Vessels 2 2
Paralysis 2 2
Paresis 2 2
Perforation 2 2
Obstruction/Occlusion 2 2
Hematoma 2 2
Dysphasia 2 2
Discomfort 2 2
Complaint, Ill-Defined 1 1
Radiodermatitis 1 1
Therapeutic Response, Decreased 1 1
Anxiety 1 1
Spinal Cord Injury 1 1
Skin Inflammation 1 1
Post Operative Wound Infection 1 1
Deformity/ Disfigurement 1 1
Dyskinesia 1 1
Numbness 1 1
Pneumothorax 1 1
Loss of Range of Motion 1 1
Staphylococcus Aureus 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Great Vessel Perforation 1 1
Twitching 1 1
Dizziness 1 1
Ventricular Fibrillation 1 1
Hearing Impairment 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
High Blood Pressure/ Hypertension 1 1
Damage to Ligament(s) 1 1
Memory Loss/Impairment 1 1
Nerve Damage 1 1
Neuropathy 1 1
Dyspnea 1 1
Emotional Changes 1 1
Perinatal Brain Injury 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Apnea 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Cardiovascular Insufficiency 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Heart Problem 1 1
Respiratory Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Feb-16-2024
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 OEC Medical Systems, Inc II Jul-31-2023
13 GE OEC Medical Systems, Inc II Jul-29-2021
14 Medtronic Navigation, Inc.-Littleton II Aug-24-2023
15 Medtronic Navigation, Inc.-Littleton II Dec-31-2019
16 NRT X-RAY A/S II May-31-2023
17 NRT X-RAY A/S II Jan-25-2022
18 PHILIPS HOME HEALTHCARE SOLUTION II Jan-28-2021
19 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-22-2024
20 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
21 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
22 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
23 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
24 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
25 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-26-2024
26 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Dec-15-2023
27 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-14-2023
28 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-30-2023
29 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-02-2023
30 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Apr-20-2023
31 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-03-2022
32 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-17-2022
33 Philips Healthcare II Apr-05-2022
34 Philips Healthcare II Mar-23-2022
35 Philips Healthcare II Nov-24-2021
36 Philips Healthcare II Nov-24-2021
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 North America, LLC II Sep-30-2020
41 Philips North America, LLC II May-08-2020
42 Philips North America, LLC II Apr-29-2020
43 Philips North America, LLC II Mar-13-2020
44 Philips North America, LLC II Feb-10-2020
45 Philips North America, LLC II Aug-06-2019
46 Philips North America, LLC II Mar-23-2019
47 Philips North America Llc II Apr-28-2023
48 Philips North America Llc II Mar-04-2022
49 Philips North America Llc II Jan-10-2022
50 Philips North America Llc II Jan-10-2022
51 Philips North America Llc II Dec-22-2021
52 Philips North America Llc II Dec-09-2021
53 Philips North America Llc II Sep-14-2021
54 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Mar-14-2024
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 Siemens Medical Solutions USA, Inc II Apr-18-2024
60 Siemens Medical Solutions USA, Inc II Dec-09-2023
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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