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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
CHINAN BIOMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FORTE AUTOMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEONI CIA CABLE SYSTEM
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
Computer Software Problem 3 3
Application Program Problem 3 3
Alarm Not Visible 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
Output Problem 1 1
Positioning Problem 1 1
Programming Issue 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 2 2
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 Elekta, Inc. II Jul-24-2018
2 Elekta, Inc. II Mar-19-2015
3 Forte Automation Systems Inc II Jul-25-2018
4 LEONI CIA CABLE SYSTEMS II Nov-21-2023
5 Med Tec Inc II Feb-21-2018
6 Med Tec Inc II Jun-15-2016
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