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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
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 3
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
INTRAOP MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASSACHUSETTS GENERAL HOSPITAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Detachment of device component 2
Positioning Issue 2
Protective measure issue 1
Computer software issue 1
Use of Incorrect Control Settings 1
Unexpected therapeutic results 1
Malposition of device 1
Device operates differently than expected 1
Human-Device Interface Issue 1
Total Device Problems 11

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 1 0 0 0 0 0 5 2 2 7
Class III 0 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hitachi America, Ltd., Power Systems Division II Jul-18-2015
2 Hitachi Medical Systems America Inc III Jul-24-2008
3 Intraop Medical Corporation II Oct-03-2008
4 Ion Beam Applications S.A. II Jul-04-2017
5 Ion Beam Applications S.A. II Jul-03-2017
6 Ion Beam Applications S.A. II Jun-19-2017
7 Ion Beam Applications S.A. II May-03-2017
8 Ion Beam Applications S.A. II Apr-17-2017
9 Ion Beam Applications S.A. II Mar-23-2017
10 Ion Beam Applications S.A. II Dec-19-2014
11 Ion Beam Applications S.A. II Apr-24-2014
12 Mevion Medical Systems, Inc. II Feb-02-2017
13 Mevion Medical Systems, Inc. II Apr-20-2016
14 Mevion Medical Systems, Inc. II Feb-08-2016
15 Mevion Medical Systems, Inc. II Dec-12-2014
16 Mevion Medical Systems, Inc. II Mar-22-2014
17 Mizuho Orthopedic Systems Inc II Dec-13-2007
18 Philips Electronics North America Corporation II Jul-22-2015
19 VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH II Jun-21-2014

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