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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
EMPNIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HIGH-TECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI, LTD. RADIATION ONCOLOGY SYSTEMS, KASHIWANOHA
  SUBSTANTIALLY EQUIVALENT 2
MEVION MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
P-CURE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 24 24
2022 10 10
2023 7 7
2024 2 2
2025 11 11
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Collision 11 11
Computer Software Problem 7 7
Device Fell 5 5
Detachment of Device or Device Component 5 5
Failure to Align 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Application Program Problem: Medication Error 3 3
Calibration Problem 3 3
Inaccurate Delivery 3 3
Therapy Delivered to Incorrect Body Area 3 3
Malposition of Device 2 2
Insufficient Information 2 2
Fail-Safe Did Not Operate 2 2
Positioning Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Failure to Read Input Signal 1 1
Device Slipped 1 1
Compatibility Problem 1 1
Radiation Underexposure 1 1
Radiation Output Problem 1 1
Break 1 1
Mechanical Problem 1 1
Device Operational Issue 1 1
Output Problem 1 1
Failure to Auto Stop 1 1
Radiation Overexposure 1 1
Fail-Safe Problem 1 1
Program or Algorithm Execution Problem 1 1
Use of Device Problem 1 1
Component Missing 1 1
Application Program Problem: Dose Calculation Error 1 1
Device Unsafe to Use in Environment 1 1
Application Program Problem: Parameter Calculation Error 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Unintended System Motion 1 1
Application Network Problem 1 1
Intermittent Program or Algorithm Execution 1 1
Mechanical Jam 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
Insufficient Information 16 16
Fall 3 3
Pain 3 3
Wound Dehiscence 2 2
Radiodermatitis 2 2
Swelling/ Edema 2 2
Cancer 2 2
Ambulation Difficulties 2 2
Abdominal Pain 1 1
Impaired Healing 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Crushing Injury 1 1
Purulent Discharge 1 1
Post Operative Wound Infection 1 1
Chills 1 1
Erythema 1 1
Nerve Damage 1 1
Balance Problems 1 1
Unspecified Kidney or Urinary Problem 1 1
Abscess 1 1
Fluid Discharge 1 1
Partial thickness (Second Degree) Burn 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hitachi America, Ltd., Particle Therapy Division II Sep-12-2024
2 Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha II Feb-20-2026
3 Ion Beam Applications S.A. II Mar-06-2026
4 Ion Beam Applications S.A. II Sep-10-2024
5 Ion Beam Applications S.A. II Aug-21-2024
6 Ion Beam Applications S.A. II Jun-03-2024
7 Ion Beam Applications S.A. II Apr-19-2024
8 Ion Beam Applications S.A. II Nov-14-2023
9 Ion Beam Applications S.A. II May-27-2022
10 Ion Beam Applications S.A. II Mar-10-2022
11 Ion Beam Applications S.A. II Jan-07-2022
12 Ion Beam Applications S.A. II Sep-08-2021
13 Ion Beam Applications S.A. II Jul-28-2021
14 Mevion Medical Systems, Inc. II Mar-25-2022
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