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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, radiation therapy, charged-particle, medical
Regulation Description Medical charged-particle radiation therapy system.
Product CodeLHN
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ANZAI MEDICAL CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI LTD.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI, LTD.
  SUBSTANTIALLY EQUIVALENT 1
IBA DOSIMETRY GMBH
  SUBSTANTIALLY EQUIVALENT 2
ION BEAM APPLICATIONS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEVION MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ORFIT INDUSTRIES NV
  SUBSTANTIALLY EQUIVALENT 1
PRONOVA SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUMITOMO HEAVY INDUSTRIES, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 7 7
2018 7 7
2019 3 3
2020 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 7 7
Device Operates Differently Than Expected 4 4
Computer Software Problem 3 3
Positioning Problem 3 3
Imprecision 2 2
Detachment Of Device Component 2 2
Component Falling 2 2
Failure to Transmit Record 2 2
Failure to Auto Stop 2 2
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Application Program Problem: Medication Error 1 1
Device Operational Issue 1 1
Device Dislodged or Dislocated 1 1
Loss of Data 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Read Input Signal 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Application Program Problem: Parameter Calculation Error 1 1
Data Problem 1 1
Use of Incorrect Control Settings 1 1
Fluid Leak 1 1
Device Slipped 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Failure to Align 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 4 4
Radiation Underdose 3 3
Radiation Overdose 2 2
Radiation Exposure, Unintended 2 2
Fibrosis 1 1
No Information 1 1
Syncope 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Death 1 1
Necrosis 1 1
Pain 1 1
Visual Impairment 1 1
Dysphasia 1 1
Complaint, Ill-Defined 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
Ambulation Difficulties 1 1
Pulmonary Embolism 1 1
Abrasion 1 1
Dyspnea 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Elekta, Inc. II Sep-06-2017
2 Hitachi America, Ltd., Power Systems Division II Jun-28-2019
3 Hitachi America, Ltd., Power Systems Division II Jul-18-2015
4 Ion Beam Applications S.A. II Aug-07-2020
5 Ion Beam Applications S.A. II Jul-27-2020
6 Ion Beam Applications S.A. II Jan-08-2019
7 Ion Beam Applications S.A. II Oct-11-2018
8 Ion Beam Applications S.A. II Jul-17-2018
9 Ion Beam Applications S.A. II Jun-23-2018
10 Ion Beam Applications S.A. II Jun-20-2018
11 Ion Beam Applications S.A. II Jun-12-2018
12 Ion Beam Applications S.A. II Jun-08-2018
13 Ion Beam Applications S.A. II Jun-07-2018
14 Ion Beam Applications S.A. II Mar-09-2018
15 Ion Beam Applications S.A. II Mar-09-2018
16 Ion Beam Applications S.A. II Mar-09-2018
17 Ion Beam Applications S.A. II Mar-08-2018
18 Ion Beam Applications S.A. II Mar-08-2018
19 Ion Beam Applications S.A. II Jul-04-2017
20 Ion Beam Applications S.A. II Jul-03-2017
21 Ion Beam Applications S.A. II Jun-19-2017
22 Ion Beam Applications S.A. II May-03-2017
23 Ion Beam Applications S.A. II Apr-17-2017
24 Ion Beam Applications S.A. II Mar-23-2017
25 Mevion Medical Systems, Inc. II Jun-22-2020
26 Mevion Medical Systems, Inc. II Jan-09-2019
27 Mevion Medical Systems, Inc. II Aug-11-2018
28 Mevion Medical Systems, Inc. II Feb-02-2017
29 Mevion Medical Systems, Inc. II Apr-20-2016
30 Mevion Medical Systems, Inc. II Feb-08-2016
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