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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, uptake, nuclear
Product CodeIZD
Regulation Number 892.1320
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 6 6
2018 4 4
2019 3 3
2020 1 1
2021 1 1
2022 3 3
2023 6 6
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11 11
Detachment of Device or Device Component 6 6
Detachment Of Device Component 5 5
Loss of or Failure to Bond 2 2
Therapeutic or Diagnostic Output Failure 1 1
Failure to Calibrate 1 1
Failure to Reset 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Defective Component 1 1
Device Inoperable 1 1
Fire 1 1
Material Separation 1 1
Insufficient Information 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
No Patient Involvement 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Capintec Inc II Mar-24-2020
2 Capintec Inc II Dec-04-2018
3 Devicor Medical Products Inc III Oct-08-2020
4 Mirion Technologies (Capintec), Inc. II Feb-09-2024
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