TPLC - Total Product Life Cycle

• Device: system, radiation therapy, charged-particle, medical
• Regulation Description: Medical charged-particle radiation therapy system.
• Product Code: LHN
• Regulation Number: 892.5050
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
HITACHI LTD.
	SUBSTANTIALLY EQUIVALENT	1
HITACHI, LTD. RADIATION ONCOLOGY SYSTEMS, KASHIWANOHA
	SUBSTANTIALLY EQUIVALENT	2
IBA DOSIMETRY GMBH
	SUBSTANTIALLY EQUIVALENT	2
ORFIT INDUSTRIES NV
	SUBSTANTIALLY EQUIVALENT	1
P-CURE LTD.
	SUBSTANTIALLY EQUIVALENT	1
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	20	20
2021	24	24
2022	10	10
2023	7	7
2024	2	2
2025	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Collision	15	15
Computer Software Problem	10	10
Inaccurate Delivery	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Failure to Align	4	4
Device Fell	4	4
Calibration Problem	3	3
Application Program Problem: Medication Error	3	3
Therapy Delivered to Incorrect Body Area	2	2
Detachment of Device or Device Component	2	2
Imprecision	2	2
Failure to Transmit Record	2	2
Fail-Safe Did Not Operate	2	2
Insufficient Information	2	2
Unintended Movement	2	2
Energy Output Problem	2	2
Mechanical Problem	2	2
Radiation Overexposure	1	1
Failure to Auto Stop	1	1
Fail-Safe Problem	1	1
Program or Algorithm Execution Problem	1	1
Output Problem	1	1
Difficult or Delayed Activation	1	1
Device Operational Issue	1	1
Application Program Problem: Dose Calculation Error	1	1
Device Damaged by Another Device	1	1
Malposition of Device	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Unsafe to Use in Environment	1	1
Data Problem	1	1
Break	1	1
No Apparent Adverse Event	1	1
Radiation Output Problem	1	1
Radiation Underexposure	1	1
Unintended System Motion	1	1
Application Network Problem	1	1
Human-Device Interface Problem	1	1
Delayed Program or Algorithm Execution	1	1
Intermittent Program or Algorithm Execution	1	1
Mechanical Jam	1	1
Unexpected/Unintended Radiation Output	1	1
Intermittent Communication Failure	1	1
Compatibility Problem	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	30	30
Insufficient Information	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Erythema	3	3
Wound Dehiscence	2	2
Fall	2	2
Pain	2	2
Radiation Underdose	2	2
Radiodermatitis	2	2
Swelling/ Edema	2	2
Cancer	2	2
Ambulation Difficulties	2	2
Unintended Radiation Exposure	2	2
Abdominal Pain	1	1
Impaired Healing	1	1
Patient Problem/Medical Problem	1	1
Crushing Injury	1	1
Purulent Discharge	1	1
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Chills	1	1
Nerve Damage	1	1
Balance Problems	1	1
Unspecified Kidney or Urinary Problem	1	1
Abscess	1	1
Fluid Discharge	1	1
Radiation Overdose	1	1
Bacterial Infection	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hitachi America, Ltd., Particle Therapy Division	II	Sep-12-2024
2	Ion Beam Applications S.A.	II	Sep-10-2024
3	Ion Beam Applications S.A.	II	Aug-21-2024
4	Ion Beam Applications S.A.	II	Jun-03-2024
5	Ion Beam Applications S.A.	II	Apr-19-2024
6	Ion Beam Applications S.A.	II	Nov-14-2023
7	Ion Beam Applications S.A.	II	May-27-2022
8	Ion Beam Applications S.A.	II	Mar-10-2022
9	Ion Beam Applications S.A.	II	Jan-07-2022
10	Ion Beam Applications S.A.	II	Sep-08-2021
11	Ion Beam Applications S.A.	II	Jul-28-2021
12	Ion Beam Applications S.A.	II	Aug-07-2020
13	Ion Beam Applications S.A.	II	Jul-27-2020
14	Mevion Medical Systems, Inc.	II	Mar-25-2022
15	Mevion Medical Systems, Inc.	II	Nov-24-2020
16	Mevion Medical Systems, Inc.	II	Jun-22-2020