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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device couch, radiation therapy, powered
Product CodeJAI
Regulation Number 892.5770
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
CHINAN BIOMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FORTE AUTOMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LEONI CIA CABLE SYSTEM
  SUBSTANTIALLY EQUIVALENT 1
MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
WFR/AQUAPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 2 2
2017 3 3
2019 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 4 4
Application Program Problem 3 3
Computer Software Problem 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Device Stops Intermittently 1 1
Use of Device Problem 1 1
Inaccurate Delivery 1 1
Malposition of Device 1 1
Computer Operating System Problem 1 1
Alarm Not Visible 1 1
Output Problem 1 1
Positioning Problem 1 1
Programming Issue 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 3 3
No Information 1 1
Cancer 1 1
Fall 1 1
Head Injury 1 1
Nausea 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Inc II Jan-11-2011
2 Accuray Inc II Jan-14-2009
3 Accuray Incorporated II Apr-20-2013
4 Elekta, Inc. II Jul-24-2018
5 Elekta, Inc. II Mar-19-2015
6 Elekta, Inc. II Apr-25-2014
7 Elekta, Inc. II Apr-09-2013
8 Elekta, Inc. II Feb-03-2011
9 Elekta, Inc. II Apr-23-2010
10 Forte Automation Systems Inc II Jul-25-2018
11 LEONI CIA CABLE SYSTEMS II Nov-21-2023
12 Med Tec Inc II Feb-21-2018
13 Med Tec Inc II Jun-15-2016
14 Siemens Medical Solutions USA, Inc II Jan-17-2014
15 Siemens Medical Solutions USA, Inc II Apr-19-2011
16 Siemens Medical Solutions USA, Inc II Oct-28-2010
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