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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
EHMETDX, LLC
  SUBSTANTIALLY EQUIVALENT 1
HITACHI LTD.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI LTD. HEALTHCARE HITACHI WORKS
  SUBSTANTIALLY EQUIVALENT 1
HITACHI, LTD. RADIATION ONCOLOGY SYSTEMS, KASHIWANOHA
  SUBSTANTIALLY EQUIVALENT 1
IBA DOSIMETRY GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORFIT INDUSTRIES NV
  SUBSTANTIALLY EQUIVALENT 1
P-CURE LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROTOM INTERNATIONAL HOLDING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 8 8
2019 3 3
2020 20 20
2021 24 24
2022 10 10
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Collision 15 15
Computer Software Problem 11 11
Adverse Event Without Identified Device or Use Problem 6 6
Malposition of Device 5 5
Inaccurate Delivery 5 5
Failure to Align 5 5
Device Fell 4 4
Insufficient Information 3 3
Application Program Problem: Medication Error 3 3
Calibration Problem 3 3
Detachment of Device or Device Component 3 3
Failure to Auto Stop 2 2
Imprecision 2 2
Mechanical Problem 2 2
Energy Output Problem 2 2
Failure to Transmit Record 2 2
Fail-Safe Did Not Operate 2 2
Unintended Movement 2 2
No Apparent Adverse Event 1 1
Difficult or Delayed Activation 1 1
Radiation Output Problem 1 1
Unexpected/Unintended Radiation Output 1 1
Program or Algorithm Execution Problem 1 1
Delayed Program or Algorithm Execution 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
Therapy Delivered to Incorrect Body Area 1 1
Unintended System Motion 1 1
Break 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Use of Incorrect Control/Treatment Settings 1 1
Application Program Problem: Dose Calculation Error 1 1
Fluid/Blood Leak 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Mechanical Jam 1 1
Output Problem 1 1
Positioning Problem 1 1
Radiation Overexposure 1 1
Radiation Underexposure 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
Insufficient Information 16 16
No Known Impact Or Consequence To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Ambulation Difficulties 3 3
Erythema 3 3
Fall 2 2
Radiation Underdose 2 2
Unintended Radiation Exposure 2 2
Swelling/ Edema 2 2
Pain 2 2
Radiodermatitis 2 2
Post Operative Wound Infection 1 1
Visual Impairment 1 1
Partial thickness (Second Degree) Burn 1 1
Radiation Exposure, Unintended 1 1
Fibrosis 1 1
Cancer 1 1
Balance Problems 1 1
Unspecified Kidney or Urinary Problem 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
Chills 1 1
Dysphasia 1 1
No Consequences Or Impact To Patient 1 1
Hematoma 1 1
Necrosis 1 1
Nerve Damage 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Radiation Overdose 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
Crushing Injury 1 1
Death 1 1
Purulent Discharge 1 1
Dyspnea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hitachi America, Ltd., Power Systems Division II Jun-28-2019
2 Ion Beam Applications S.A. II Nov-14-2023
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 Mevion Medical Systems, Inc. II Mar-25-2022
24 Mevion Medical Systems, Inc. II Nov-24-2020
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
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