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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
ANZAI MEDICAL CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI, LTD.
  SUBSTANTIALLY EQUIVALENT 1
IBA DOSIMETRY GMBH
  SUBSTANTIALLY EQUIVALENT 1
ION BEAM APPLICATIONS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEVION MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PRONOVA SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUMITOMO HEAVY INDUSTRIES, LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malposition of device 6
Component Falling 2
Failure to Auto Stop 2
Detachment Of Device Component 2
Positioning Problem 2
Use of Incorrect Control Settings 1
Device Operates Differently Than Expected 1
Human Factors Issue 1
Fluid Leak 1
Failure to Read Input Signal 1
Computer Software Problem 1
Unexpected Therapeutic Results 1
Application Program Problem: Parameter Calculation Error 1
Device Operational Issue 1
Protective Measures Problem 1
No Apparent Adverse Event 1
Human-Device Interface Problem 1
Total Device Problems 26

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 Hitachi America, Ltd., Power Systems Division II Jul-18-2015
4 Ion Beam Applications S.A. II Jan-08-2019
5 Ion Beam Applications S.A. II Oct-11-2018
6 Ion Beam Applications S.A. II Jul-17-2018
7 Ion Beam Applications S.A. II Jun-23-2018
8 Ion Beam Applications S.A. II Jun-20-2018
9 Ion Beam Applications S.A. II Jun-12-2018
10 Ion Beam Applications S.A. II Jun-08-2018
11 Ion Beam Applications S.A. II Jun-07-2018
12 Ion Beam Applications S.A. II Mar-09-2018
13 Ion Beam Applications S.A. II Mar-09-2018
14 Ion Beam Applications S.A. II Mar-09-2018
15 Ion Beam Applications S.A. II Mar-08-2018
16 Ion Beam Applications S.A. II Mar-08-2018
17 Ion Beam Applications S.A. II Jul-04-2017
18 Ion Beam Applications S.A. II Jul-03-2017
19 Ion Beam Applications S.A. II Jun-19-2017
20 Ion Beam Applications S.A. II May-03-2017
21 Ion Beam Applications S.A. II Apr-17-2017
22 Ion Beam Applications S.A. II Mar-23-2017
23 Mevion Medical Systems, Inc. II Jan-09-2019
24 Mevion Medical Systems, Inc. II Aug-11-2018
25 Mevion Medical Systems, Inc. II Feb-02-2017
26 Mevion Medical Systems, Inc. II Apr-20-2016
27 Mevion Medical Systems, Inc. II Feb-08-2016

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