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TPLC
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Device
system, therapeutic, x-ray
Product Code
JAD
Regulation Number
892.5900
Device Class
2
Premarket Reviews
Manufacturer
Decision
NUCLETRON B.V.
SUBSTANTIALLY EQUIVALENT
1
SENSUS HEALTHCARE, INC
SUBSTANTIALLY EQUIVALENT
1
SENSUS HEALTHCARE, INC.
SUBSTANTIALLY EQUIVALENT
1
XSTRAHL LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
9
9
2022
5
5
2023
2
2
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6
6
Patient Device Interaction Problem
5
5
Failure to Deliver Energy
1
1
Device Operational Issue
1
1
Output Problem
1
1
Insufficient Information
1
1
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Inadequate Instructions for Healthcare Professional
1
1
Use of Device Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Unexpected Therapeutic Results
1
1
Device Displays Incorrect Message
1
1
Unexpected/Unintended Radiation Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Tissue Breakdown
6
6
Tissue Damage
4
4
No Clinical Signs, Symptoms or Conditions
3
3
Insufficient Information
3
3
Pain
3
3
Radiation Burn
3
3
No Known Impact Or Consequence To Patient
2
2
Ulcer
2
2
No Consequences Or Impact To Patient
2
2
Unspecified Vascular Problem
2
2
Radiation Exposure, Unintended
1
1
Hair Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sensus Healthcare, Inc.
II
Mar-08-2023
2
Xstrahl Limited
II
Dec-16-2021
3
Xstrahl Limited
II
Oct-26-2021
4
Xstrahl Limited
II
Jul-19-2022
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