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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
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON INC.
  SUBSTANTIALLY EQUIVALENT 1
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 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 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 3231 3231

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 4439 4439
Radiation Output Failure 4014 4014
Application Program Freezes, Becomes Nonfunctional 3354 3354
Positioning Failure 1217 1217
Positioning Problem 1017 1017
No Display/Image 761 761
Noise, Audible 560 560
Device Sensing Problem 508 508
Communication or Transmission Problem 477 477
Use of Device Problem 475 475
Poor Quality Image 460 460
Failure to Power Up 346 346
Unexpected Shutdown 266 266
Failure to Advance 243 243
Failure to Run on Battery 239 239
Image Display Error/Artifact 221 221
Adverse Event Without Identified Device or Use Problem 219 219
Imprecision 206 206
Material Deformation 170 170
Output Problem 154 154
Mechanical Problem 154 154
Physical Resistance/Sticking 154 154
Failure to Charge 140 140
Detachment of Device or Device Component 133 133
Unintended Movement 131 131
Application Program Problem 129 129
Radiation Output Problem 121 121
Power Problem 115 115
Unintended System Motion 88 88
No Device Output 84 84
Calibration Problem 73 73
Wireless Communication Problem 69 69
Smoking 67 67
Electrical /Electronic Property Problem 67 67
Insufficient Information 64 64
Display or Visual Feedback Problem 57 57
Incorrect, Inadequate or Imprecise Result or Readings 48 48
Unintended Collision 44 44
No Apparent Adverse Event 44 44
Device Operational Issue 41 41
Device Damaged Prior to Use 40 40
Failure to Shut Off 40 40
Erratic or Intermittent Display 39 39
Data Problem 36 36
Mechanical Jam 34 34
Failure to Transmit Record 32 32
Connection Problem 31 31
Computer Software Problem 29 29
Overheating of Device 26 26
Arcing 26 26
Unexpected/Unintended Radiation Output 26 26
Loose or Intermittent Connection 25 25
Radiation Overexposure 24 24
Unintended Electrical Shock 24 24
Difficult or Delayed Activation 23 23
Computer Operating System Problem 22 22
Device Fell 22 22
Therapeutic or Diagnostic Output Failure 17 17
Operating System Becomes Nonfunctional 15 15
Component Missing 15 15
Difficult or Delayed Positioning 14 14
Malposition of Device 13 13
Appropriate Term/Code Not Available 13 13
Complete Loss of Power 12 12
Intermittent Loss of Power 12 12
Device Handling Problem 12 12
Defective Component 12 12
Fire 12 12
Unstable 12 12
Break 11 11
Temperature Problem 11 11
Defective Device 10 10
Improper or Incorrect Procedure or Method 10 10
Loss of Power 10 10
Device Displays Incorrect Message 9 9
Device Dislodged or Dislocated 9 9
Material Integrity Problem 9 9
Activation Problem 9 9
Patient Data Problem 8 8
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
Premature Discharge of Battery 8 8
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
Key or Button Unresponsive/not Working 6 6
Delayed Program or Algorithm Execution 5 5
Environmental Particulates 5 5
Entrapment of Device 5 5
Device Emits Odor 5 5
Shielding Failure 4 4
Use of Incorrect Control/Treatment Settings 4 4
Circuit Failure 4 4
Sparking 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15838 15838
No Patient Involvement 1608 1608
No Known Impact Or Consequence To Patient 1116 1116
Insufficient Information 166 166
No Consequences Or Impact To Patient 78 78
Radiation Exposure, Unintended 40 40
Unspecified Tissue Injury 28 28
Unintended Radiation Exposure 28 28
Hair Loss 22 22
Laceration(s) 17 17
Death 16 16
Injury 16 16
Fall 15 15
Bone Fracture(s) 15 15
Pain 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Tissue Damage 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
Muscle/Tendon Damage 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
Swelling/ Edema 2 2
Unspecified Vascular Problem 2 2
Convulsion/Seizure 2 2
Paresthesia 2 2
Unspecified Nervous System Problem 2 2
Aneurysm 2 2
Cardiopulmonary Arrest 2 2
Burn(s) 2 2
Headache 2 2
Ventricular Fibrillation 2 2
Perforation of Vessels 2 2
Concussion 2 2
Hematoma 2 2
Dysphasia 2 2
Paralysis 2 2
Paresis 2 2
Perforation 2 2
Obstruction/Occlusion 2 2
Pressure Sores 2 2
Discomfort 2 2
Complaint, Ill-Defined 1 1
Anxiety 1 1
Radiodermatitis 1 1
Cardiogenic Shock 1 1
Therapeutic Response, Decreased 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
Dizziness 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Great Vessel Perforation 1 1
Twitching 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
Speech Disorder 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 Medical Systems, SCS II May-06-2024
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 Jun-06-2024
16 Medtronic Navigation, Inc.-Littleton II Aug-24-2023
17 Medtronic Navigation, Inc.-Littleton II Dec-31-2019
18 NRT X-RAY A/S II May-07-2024
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 May-24-2024
23 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-22-2024
24 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
25 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
26 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
27 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
28 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
29 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-26-2024
30 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Dec-15-2023
31 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-14-2023
32 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-30-2023
33 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-02-2023
34 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Apr-20-2023
35 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-03-2022
36 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-17-2022
37 Philips Healthcare II Apr-05-2022
38 Philips Healthcare II Mar-23-2022
39 Philips Healthcare II Nov-24-2021
40 Philips Healthcare II Nov-24-2021
41 Philips Medical Systems Nederland B.V. II Sep-07-2023
42 Philips Medical Systems Nederlands II Jun-21-2021
43 Philips Medical Systems Nederlands II Jul-30-2019
44 Philips North America, LLC II Sep-30-2020
45 Philips North America, LLC II May-08-2020
46 Philips North America, LLC II Apr-29-2020
47 Philips North America, LLC II Mar-13-2020
48 Philips North America, LLC II Feb-10-2020
49 Philips North America, LLC II Aug-06-2019
50 Philips North America, LLC II Mar-23-2019
51 Philips North America Llc II Apr-28-2023
52 Philips North America Llc II Mar-04-2022
53 Philips North America Llc II Jan-10-2022
54 Philips North America Llc II Jan-10-2022
55 Philips North America Llc II Dec-22-2021
56 Philips North America Llc II Dec-09-2021
57 Philips North America Llc II Sep-14-2021
58 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Mar-14-2024
59 Shimadzu Medical Systems II Feb-28-2022
60 Shimadzu Medical Systems II Dec-10-2020
61 Shimadzu Medical Systems II Jul-14-2020
62 Shimadzu Medical Systems Usa Com II Feb-21-2019
63 Siemens Medical Solutions USA, Inc II Apr-18-2024
64 Siemens Medical Solutions USA, Inc II Dec-09-2023
65 Siemens Medical Solutions USA, Inc II Oct-27-2023
66 Siemens Medical Solutions USA, Inc II Aug-08-2023
67 Siemens Medical Solutions USA, Inc II Jul-27-2023
68 Siemens Medical Solutions USA, Inc II May-23-2023
69 Siemens Medical Solutions USA, Inc II May-02-2023
70 Siemens Medical Solutions USA, Inc II Apr-27-2023
71 Siemens Medical Solutions USA, Inc II Mar-30-2023
72 Siemens Medical Solutions USA, Inc II Feb-23-2023
73 Siemens Medical Solutions USA, Inc II Jan-30-2023
74 Siemens Medical Solutions USA, Inc II Jan-20-2023
75 Siemens Medical Solutions USA, Inc II Jan-13-2023
76 Siemens Medical Solutions USA, Inc II Aug-26-2022
77 Siemens Medical Solutions USA, Inc II Jul-07-2022
78 Siemens Medical Solutions USA, Inc II Jul-06-2022
79 Siemens Medical Solutions USA, Inc II Jun-07-2022
80 Siemens Medical Solutions USA, Inc II Apr-21-2022
81 Siemens Medical Solutions USA, Inc II Apr-21-2022
82 Siemens Medical Solutions USA, Inc II Jan-21-2022
83 Siemens Medical Solutions USA, Inc II Nov-24-2021
84 Siemens Medical Solutions USA, Inc II Nov-04-2021
85 Siemens Medical Solutions USA, Inc II Sep-02-2021
86 Siemens Medical Solutions USA, Inc II Jul-07-2021
87 Siemens Medical Solutions USA, Inc II Jun-02-2021
88 Siemens Medical Solutions USA, Inc II May-13-2021
89 Siemens Medical Solutions USA, Inc II Apr-26-2021
90 Siemens Medical Solutions USA, Inc II Apr-26-2021
91 Siemens Medical Solutions USA, Inc II Mar-22-2021
92 Siemens Medical Solutions USA, Inc II Feb-23-2021
93 Siemens Medical Solutions USA, Inc II Jan-11-2021
94 Siemens Medical Solutions USA, Inc II Nov-18-2020
95 Siemens Medical Solutions USA, Inc II Nov-04-2020
96 Siemens Medical Solutions USA, Inc II Oct-27-2020
97 Siemens Medical Solutions USA, Inc II Oct-15-2020
98 Siemens Medical Solutions USA, Inc II Aug-26-2020
99 Siemens Medical Solutions USA, Inc II Aug-22-2020
100 Siemens Medical Solutions USA, Inc II Jun-09-2020
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