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TPLC
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show TPLC since
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Device
couch, radiation therapy, powered
Product Code
JAI
Regulation Number
892.5770
Device Class
2
Premarket Reviews
Manufacturer
Decision
BRAINLAB AG
SUBSTANTIALLY EQUIVALENT
1
CHINAN BIOMEDICAL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
FORTE AUTOMATION SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
LEO CANCER CARE
SUBSTANTIALLY EQUIVALENT
1
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
Unintended Movement
1
1
Positioning Problem
1
1
Computer Operating System Problem
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Programming Issue
1
1
Mechanical Problem
1
1
Malposition of Device
1
1
Output Problem
1
1
Alarm Not Visible
1
1
Loose or Intermittent Connection
1
1
Use of Device Problem
1
1
Device Stops Intermittently
1
1
Inaccurate Delivery
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
3
3
No Patient Involvement
3
3
Nausea
1
1
No Information
1
1
Head Injury
1
1
Fall
1
1
Pain
1
1
No Consequences Or Impact To Patient
1
1
Cancer
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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