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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
Product CodeLHN
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ANZAI MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EHMETDX, LLC
  SUBSTANTIALLY EQUIVALENT 1
HITACHI LTD.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI LTD. HEALTHCARE HITACHI WORKS
  SUBSTANTIALLY EQUIVALENT 1
HITACHI, LTD. HEALTHCARE
  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
PROTOM INTERNATIONAL HOLDING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 7 7
2018 7 7
2019 3 3
2020 20 20
2021 24 24
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Collision 14 14
Computer Software Problem 11 11
Malposition of Device 7 7
Inaccurate Delivery 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Positioning Problem 3 3
Failure to Auto Stop 3 3
Application Program Problem: Medication Error 3 3
Device Fell 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Fail-Safe Did Not Operate 2 2
Failure to Align 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Human-Device Interface Problem 2 2
Use of Incorrect Control Settings 2 2
Detachment Of Device Component 2 2
Component Falling 2 2
Imprecision 2 2
Mechanical Problem 2 2
Energy Output Problem 2 2
Failure to Transmit Record 2 2
Failure to Read Input Signal 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Application Program Problem: Parameter Calculation Error 1 1
Therapy Delivered to Incorrect Body Area 1 1
Unintended System Motion 1 1
Application Program Problem: Dose Calculation Error 1 1
Fluid Leak 1 1
Compatibility Problem 1 1
Mechanical Jam 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Radiation Overexposure 1 1
Radiation Underexposure 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Difficult or Delayed Activation 1 1
Human Factors Issue 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Radiation Output Problem 1 1
Unexpected/Unintended Radiation Output 1 1
Delayed Program or Algorithm Execution 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Insufficient Information 13 13
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Erythema 3 3
Pain 3 3
Radiation Underdose 3 3
Radiation Overdose 2 2
Unintended Radiation Exposure 2 2
Swelling/ Edema 2 2
Radiodermatitis 2 2
Ambulation Difficulties 2 2
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
Post Operative Wound Infection 1 1
Radiation Exposure, Unintended 1 1
Fibrosis 1 1
Unspecified Kidney or Urinary Problem 1 1
Syncope 1 1
Abdominal Pain 1 1
Abrasion 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Death 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Chills 1 1
Dysphasia 1 1
Visual Impairment 1 1
Hematoma 1 1
Necrosis 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 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 Ion Beam Applications S.A. II May-27-2022
4 Ion Beam Applications S.A. II Mar-10-2022
5 Ion Beam Applications S.A. II Jan-07-2022
6 Ion Beam Applications S.A. II Sep-08-2021
7 Ion Beam Applications S.A. II Jul-28-2021
8 Ion Beam Applications S.A. II Aug-07-2020
9 Ion Beam Applications S.A. II Jul-27-2020
10 Ion Beam Applications S.A. II Jan-08-2019
11 Ion Beam Applications S.A. II Oct-11-2018
12 Ion Beam Applications S.A. II Jul-17-2018
13 Ion Beam Applications S.A. II Jun-23-2018
14 Ion Beam Applications S.A. II Jun-20-2018
15 Ion Beam Applications S.A. II Jun-12-2018
16 Ion Beam Applications S.A. II Jun-08-2018
17 Ion Beam Applications S.A. II Jun-07-2018
18 Ion Beam Applications S.A. II Mar-09-2018
19 Ion Beam Applications S.A. II Mar-09-2018
20 Ion Beam Applications S.A. II Mar-09-2018
21 Ion Beam Applications S.A. II Mar-08-2018
22 Ion Beam Applications S.A. II Mar-08-2018
23 Ion Beam Applications S.A. II Jul-04-2017
24 Ion Beam Applications S.A. II Jul-03-2017
25 Ion Beam Applications S.A. II Jun-19-2017
26 Ion Beam Applications S.A. II May-03-2017
27 Ion Beam Applications S.A. II Apr-17-2017
28 Ion Beam Applications S.A. II Mar-23-2017
29 Mevion Medical Systems, Inc. II Mar-25-2022
30 Mevion Medical Systems, Inc. II Nov-24-2020
31 Mevion Medical Systems, Inc. II Jun-22-2020
32 Mevion Medical Systems, Inc. II Jan-09-2019
33 Mevion Medical Systems, Inc. II Aug-11-2018
34 Mevion Medical Systems, Inc. II Feb-02-2017
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