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TPLC
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show TPLC since
2009
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2011
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2013
2014
2015
2016
2017
2018
2019
2020
2021
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2023
2024
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Device
treadmill, powered
Product Code
IOL
Regulation Number
890.5380
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
12
12
2016
1
1
2017
4
4
2018
4
4
2019
6
6
2020
1
1
2021
1
1
2022
1
1
2023
6
6
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
11
11
Unintended Movement
5
5
Self-Activation or Keying
4
4
Mechanical Problem
3
3
Protective Measures Problem
3
3
Failure to Shut Off
2
2
Unintended System Motion
2
2
Improper or Incorrect Procedure or Method
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Operating System Becomes Nonfunctional
1
1
Insufficient Information
1
1
Device Stops Intermittently
1
1
Electrical /Electronic Property Problem
1
1
Output Problem
1
1
Break
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Use of Device Problem
1
1
Calibration Error
1
1
Programming Issue
1
1
Device Emits Odor
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
16
16
No Known Impact Or Consequence To Patient
14
14
Abrasion
5
5
No Consequences Or Impact To Patient
5
5
Bone Fracture(s)
4
4
Injury
3
3
No Patient Involvement
3
3
No Clinical Signs, Symptoms or Conditions
2
2
Fracture, Arm
1
1
Joint Dislocation
1
1
Arthralgia
1
1
Fatigue
1
1
No Information
1
1
Multiple Fractures
1
1
Hematoma
1
1
Loss of Range of Motion
1
1
Discomfort
1
1
Insufficient Information
1
1
Pain
1
1
Loss of consciousness
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AlterG, Incorporated
II
Mar-04-2014
2
Cardiac Science Corporation
II
Jun-04-2010
3
Full Vision Inc
II
Jun-30-2023
4
Full Vision Inc
II
Dec-03-2022
5
GE Healthcare
II
Jun-22-2015
6
GE Healthcare
II
Mar-17-2015
7
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
II
Jul-16-2018
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