TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
HITACHI LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
PROTOM INTERNATIONAL HOLDING CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	3	3
2020	20	20
2021	24	24
2022	10	10
2023	7	7
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Collision	15	15
Computer Software Problem	10	10
Adverse Event Without Identified Device or Use Problem	6	6
Inaccurate Delivery	5	5
Failure to Align	4	4
Device Fell	4	4
Application Program Problem: Medication Error	3	3
Calibration Problem	3	3
Detachment of Device or Device Component	2	2
Unintended Movement	2	2
Insufficient Information	2	2
Malposition of Device	2	2
Therapy Delivered to Incorrect Body Area	2	2
Failure to Transmit Record	2	2
Imprecision	2	2
Mechanical Problem	2	2
Energy Output Problem	2	2
Fail-Safe Did Not Operate	2	2
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
Application Program Problem: Parameter Calculation Error	1	1
Unintended System Motion	1	1
Use of Incorrect Control/Treatment Settings	1	1
Application Program Problem: Dose Calculation Error	1	1
Failure to Read Input Signal	1	1
Device Slipped	1	1
Break	1	1
Difficult or Delayed Activation	1	1
Appropriate Term/Code Not Available	1	1
Data Problem	1	1
No Apparent Adverse Event	1	1
Output Problem	1	1
Radiation Overexposure	1	1
Radiation Underexposure	1	1
Device Damaged by Another Device	1	1
Device Unsafe to Use in Environment	1	1
Fail-Safe Problem	1	1
Failure to Auto Stop	1	1
Human-Device Interface Problem	1	1
Compatibility Problem	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	28	28
Insufficient Information	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Erythema	3	3
Ambulation Difficulties	3	3
Fall	2	2
Pain	2	2
Radiation Underdose	2	2
Radiodermatitis	2	2
Unintended Radiation Exposure	2	2
Swelling/ Edema	2	2
Post Operative Wound Infection	1	1
Chills	1	1
Dysphasia	1	1
Visual Impairment	1	1
Necrosis	1	1
Nerve Damage	1	1
Wound Dehiscence	1	1
Radiation Overdose	1	1
Abdominal Pain	1	1
Bacterial Infection	1	1
Bruise/Contusion	1	1
Crushing Injury	1	1
Purulent Discharge	1	1
Patient Problem/Medical Problem	1	1
No Known Impact Or Consequence To Patient	1	1
Radiation Exposure, Unintended	1	1
Fibrosis	1	1
Cancer	1	1
Balance Problems	1	1
Unspecified Kidney or Urinary Problem	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	Apr-19-2024
3	Ion Beam Applications S.A.	II	Nov-14-2023
4	Ion Beam Applications S.A.	II	May-27-2022
5	Ion Beam Applications S.A.	II	Mar-10-2022
6	Ion Beam Applications S.A.	II	Jan-07-2022
7	Ion Beam Applications S.A.	II	Sep-08-2021
8	Ion Beam Applications S.A.	II	Jul-28-2021
9	Ion Beam Applications S.A.	II	Aug-07-2020
10	Ion Beam Applications S.A.	II	Jul-27-2020
11	Ion Beam Applications S.A.	II	Jan-08-2019
12	Mevion Medical Systems, Inc.	II	Mar-25-2022
13	Mevion Medical Systems, Inc.	II	Nov-24-2020
14	Mevion Medical Systems, Inc.	II	Jun-22-2020
15	Mevion Medical Systems, Inc.	II	Jan-09-2019