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TPLC
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Device
probe, uptake, nuclear
Regulation Description
Nuclear uptake probe.
Product Code
IZD
Regulation Number
892.1320
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
1
1
2021
1
1
2022
3
3
2023
6
6
2024
7
7
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
7
7
Detachment of Device or Device Component
6
6
Insufficient Information
2
2
Device Reprocessing Problem
1
1
Failure to Reset
1
1
Defective Component
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Therapeutic or Diagnostic Output Failure
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13
13
Bacterial Infection
1
1
Breast Cancer
1
1
Unspecified Tissue Injury
1
1
Skin Discoloration
1
1
Nodule
1
1
No Consequences Or Impact To Patient
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Capintec Inc
II
Mar-24-2020
2
Devicor Medical Products Inc
III
Oct-08-2020
3
Mirion Technologies (Capintec), Inc.
II
May-24-2024
4
Mirion Technologies (Capintec), Inc.
II
Feb-09-2024
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