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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 8
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
GE HUALUN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEMSS MEDICAL SYSTEMS CO., LTD
  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 2
MICRONICA SRL
  SUBSTANTIALLY EQUIVALENT 1
MX IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
NRT X-RAY A/S
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
NVIEW MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NVIEW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS INDIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL STYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 8
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 1
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
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
TOSHIBA MEDICAL SYSTEMS COROPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TRACK X TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRACKX TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 1604 1604
2018 1449 1449
2019 1558 1558
2020 1581 1581
2021 1981 1981
2022 732 732

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 2201 2201
Device Operates Differently Than Expected 972 972
Positioning Problem 692 692
Communication or Transmission Problem 637 637
Radiation Output Failure 494 494
Use of Device Problem 467 467
Electrical /Electronic Property Problem 421 421
Device Inoperable 418 418
Noise, Audible 378 378
Device Displays Incorrect Message 319 319
Failure to Power Up 297 297
Poor Quality Image 296 296
Device Sensing Problem 291 291
Failure to Run on Battery 249 249
Device Stops Intermittently 241 241
Insufficient Information 189 189
Material Deformation 170 170
Mechanical Problem 170 170
Adverse Event Without Identified Device or Use Problem 168 168
Difficult to Open or Close 163 163
Imprecision 157 157
Calibration Problem 148 148
Failure to Charge 145 145
Unexpected Shutdown 110 110
Image Display Error/Artifact 108 108
Computer Software Problem 106 106
Physical Resistance/Sticking 100 100
No Display/Image 96 96
Power Problem 96 96
Output Problem 87 87
Unintended Movement 83 83
Application Interface Becomes Non-Functional Or Program Exits Abnormally 82 82
Wireless Communication Problem 79 79
No Apparent Adverse Event 53 53
Display or Visual Feedback Problem 52 52
Device Operational Issue 44 44
Radiation Output Problem 40 40
Failure to Shut Off 39 39
Break 36 36
Device Damaged Prior to Use 34 34
Detachment of Device or Device Component 33 33
Loss of Data 32 32
Smoking 32 32
Loose or Intermittent Connection 24 24
Data Problem 23 23
Loss of Power 20 20
No Device Output 20 20
Overheating of Device 20 20
Application Program Problem 20 20
Connection Problem 19 19
Arcing 19 19
Radiation Overexposure 17 17
Computer Operating System Problem 16 16
Improper or Incorrect Procedure or Method 16 16
Positioning Failure 14 14
Failure to Obtain Sample 14 14
Therapeutic or Diagnostic Output Failure 13 13
Patient Data Problem 13 13
Unintended Collision 12 12
Bent 11 11
Defective Component 11 11
Device Fell 11 11
Unintended Electrical Shock 10 10
Unexpected/Unintended Radiation Output 9 9
Device Handling Problem 9 9
Defective Device 9 9
Temperature Problem 9 9
Installation-Related Problem 9 9
Material Integrity Problem 8 8
Mechanical Jam 8 8
No Flow 8 8
Erratic or Intermittent Display 8 8
Device Emits Odor 8 8
Unintended System Motion 7 7
Human-Device Interface Problem 7 7
Component Missing 7 7
Device Dislodged or Dislocated 6 6
Operating System Becomes Nonfunctional 6 6
Optical Problem 6 6
Material Twisted/Bent 5 5
Missing Value Reason 5 5
Failure to Fire 5 5
Device Remains Activated 5 5
Self-Activation or Keying 5 5
Premature Discharge of Battery 5 5
Intermittent Communication Failure 5 5
Activation Failure 4 4
Thermal Decomposition of Device 4 4
Detachment Of Device Component 4 4
Entrapment of Device 4 4
Fire 4 4
Leak/Splash 4 4
Device Slipped 4 4
Appropriate Term/Code Not Available 4 4
Problem with Software Installation 4 4
Sparking 3 3
Device Difficult to Setup or Prepare 3 3
Fluid Leak 3 3
Component Falling 3 3
Insufficient Cooling 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3260 3260
No Clinical Signs, Symptoms or Conditions 2979 2979
No Known Impact Or Consequence To Patient 1987 1987
No Consequences Or Impact To Patient 514 514
Radiation Exposure, Unintended 51 51
Injury 43 43
Death 40 40
Unintended Radiation Exposure 24 24
Insufficient Information 23 23
Hair Loss 18 18
Patient Problem/Medical Problem 16 16
Cardiac Arrest 15 15
Bone Fracture(s) 15 15
Tissue Damage 14 14
No Code Available 14 14
Radiation Overdose 13 13
Laceration(s) 12 12
Bruise/Contusion 11 11
Unspecified Tissue Injury 11 11
No Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Radiation Burn 7 7
Fall 7 7
Electric Shock 7 7
Iatrogenic Source 6 6
Burn(s) 6 6
Crushing Injury 5 5
Abrasion 5 5
Head Injury 5 5
Hemorrhage/Bleeding 4 4
Myocardial Infarction 3 3
Overdose 3 3
Pain 3 3
Contusion 3 3
Sudden Cardiac Death 3 3
Embolism/Embolus 3 3
Missing Value Reason 2 2
Vascular Dissection 2 2
Muscle/Tendon Damage 2 2
Skin Inflammation 2 2
Suture Abrasion 2 2
Underdose 2 2
Superficial (First Degree) Burn 2 2
Concussion 2 2
Seizures 2 2
Radiodermatitis 2 2
Erythema 2 2
Cardiopulmonary Arrest 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Headache 1 1
Hematoma 1 1
Paralysis 1 1
Perforation 1 1
Pneumothorax 1 1
Staphylococcus Aureus 1 1
Nerve Damage 1 1
Muscle Weakness 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Congenital Defect/Deformity 1 1
Apnea 1 1
Bacterial Infection 1 1
Perinatal Brain Injury 1 1
Therapeutic Response, Decreased 1 1
Physical Entrapment 1 1
Complaint, Ill-Defined 1 1
Fracture, Arm 1 1
Numbness 1 1
Coma 1 1
Obstruction/Occlusion 1 1
Skin Irritation 1 1
Skull Fracture 1 1
Spinal Column Injury 1 1
Sprain 1 1
Swelling 1 1
Thrombosis 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Full thickness (Third Degree) Burn 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
Infection, Indirect 1 1
Cardiac Perforation 1 1
Burn, Thermal 1 1
Unspecified Musculoskeletal problem 1 1
Shock from Patient Lead(s) 1 1
Ruptured Aneurysm 1 1
Unspecified Vascular Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Barco N.V. II Nov-30-2018
2 Canon Medical System, USA, INC. II Jun-24-2022
3 Canon Medical System, USA, INC. II Jan-12-2022
4 Canon Medical System, USA, INC. II Mar-17-2021
5 Canon Medical System, USA, INC. II Mar-09-2021
6 Canon Medical System, USA, INC. II Dec-03-2020
7 Canon Medical System, USA, INC. II Aug-25-2020
8 Canon Medical System, USA, INC. II Jun-09-2020
9 GE Healthcare, LLC II Jun-15-2021
10 GE Medical Systems, SCS II Oct-05-2018
11 GE OEC Medical Systems, Inc II Jul-29-2021
12 GE OEC Medical Systems, Inc II Jan-20-2017
13 GE OEC Medical Systems, Inc II Jan-09-2017
14 Medtronic Navigation, Inc.-Littleton II Dec-31-2019
15 Medtronic Navigation, Inc.-Littleton II Nov-07-2018
16 Medtronic Navigation, Inc.-Littleton II Mar-08-2018
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 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 Electronics North America Corporation II Dec-18-2017
26 Philips Electronics North America Corporation II Apr-14-2017
27 Philips Electronics North America Corporation II Jan-20-2017
28 Philips Healthcare II Apr-05-2022
29 Philips Healthcare II Mar-23-2022
30 Philips Healthcare II Nov-24-2021
31 Philips Healthcare II Nov-24-2021
32 Philips Healthcare II Jul-25-2018
33 Philips Medical Systems Nederlands II Jun-21-2021
34 Philips Medical Systems Nederlands II Jul-30-2019
35 Philips Medical Systems Nederlands II Jun-27-2018
36 Philips North America, LLC II Sep-30-2020
37 Philips North America, LLC II May-08-2020
38 Philips North America, LLC II Apr-29-2020
39 Philips North America, LLC II Mar-13-2020
40 Philips North America, LLC II Feb-10-2020
41 Philips North America, LLC II Aug-06-2019
42 Philips North America, LLC II Mar-23-2019
43 Philips North America Llc II Mar-04-2022
44 Philips North America Llc II Jan-10-2022
45 Philips North America Llc II Jan-10-2022
46 Philips North America Llc II Dec-22-2021
47 Philips North America Llc II Dec-09-2021
48 Philips North America Llc II Sep-14-2021
49 Shimadzu Medical Systems II Feb-28-2022
50 Shimadzu Medical Systems II Dec-10-2020
51 Shimadzu Medical Systems II Jul-14-2020
52 Shimadzu Medical Systems Usa Com II Feb-21-2019
53 Shimadzu Medical Systems Usa Com II Oct-19-2018
54 Siemens Medical Solutions USA, INC II Feb-14-2018
55 Siemens Medical Solutions USA, Inc II Jun-07-2022
56 Siemens Medical Solutions USA, Inc II Apr-21-2022
57 Siemens Medical Solutions USA, Inc II Apr-21-2022
58 Siemens Medical Solutions USA, Inc II Jan-21-2022
59 Siemens Medical Solutions USA, Inc II Nov-24-2021
60 Siemens Medical Solutions USA, Inc II Nov-04-2021
61 Siemens Medical Solutions USA, Inc II Sep-02-2021
62 Siemens Medical Solutions USA, Inc II Jul-07-2021
63 Siemens Medical Solutions USA, Inc II Jun-02-2021
64 Siemens Medical Solutions USA, Inc II May-13-2021
65 Siemens Medical Solutions USA, Inc II Apr-26-2021
66 Siemens Medical Solutions USA, Inc II Apr-26-2021
67 Siemens Medical Solutions USA, Inc II Mar-22-2021
68 Siemens Medical Solutions USA, Inc II Feb-23-2021
69 Siemens Medical Solutions USA, Inc II Jan-11-2021
70 Siemens Medical Solutions USA, Inc II Nov-18-2020
71 Siemens Medical Solutions USA, Inc II Nov-04-2020
72 Siemens Medical Solutions USA, Inc II Oct-27-2020
73 Siemens Medical Solutions USA, Inc II Oct-15-2020
74 Siemens Medical Solutions USA, Inc II Aug-26-2020
75 Siemens Medical Solutions USA, Inc II Aug-22-2020
76 Siemens Medical Solutions USA, Inc II Jun-09-2020
77 Siemens Medical Solutions USA, Inc II Jun-03-2020
78 Siemens Medical Solutions USA, Inc II May-22-2020
79 Siemens Medical Solutions USA, Inc II May-04-2020
80 Siemens Medical Solutions USA, Inc II May-04-2020
81 Siemens Medical Solutions USA, Inc II Mar-13-2020
82 Siemens Medical Solutions USA, Inc II Feb-20-2020
83 Siemens Medical Solutions USA, Inc II Feb-20-2020
84 Siemens Medical Solutions USA, Inc II Feb-20-2020
85 Siemens Medical Solutions USA, Inc II Jan-13-2020
86 Siemens Medical Solutions USA, Inc II Jan-07-2020
87 Siemens Medical Solutions USA, Inc II Dec-17-2019
88 Siemens Medical Solutions USA, Inc II Aug-24-2019
89 Siemens Medical Solutions USA, Inc II Jul-22-2019
90 Siemens Medical Solutions USA, Inc II Jul-09-2019
91 Siemens Medical Solutions USA, Inc II Jun-28-2019
92 Siemens Medical Solutions USA, Inc II May-08-2019
93 Siemens Medical Solutions USA, Inc II May-07-2019
94 Siemens Medical Solutions USA, Inc II Mar-07-2019
95 Siemens Medical Solutions USA, Inc II Nov-14-2018
96 Siemens Medical Solutions USA, Inc II Sep-18-2018
97 Siemens Medical Solutions USA, Inc II Aug-11-2018
98 Siemens Medical Solutions USA, Inc II Jul-20-2018
99 Siemens Medical Solutions USA, Inc II Jul-20-2018
100 Siemens Medical Solutions USA, Inc II Jun-27-2018
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