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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
Regulation Description Nuclear uptake probe.
Product CodeIZD
Regulation Number 892.1320
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3
2023 6 6
2024 7 7
2025 8 8
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Detachment of Device or Device Component 6 6
Mechanical Problem 6 6
Insufficient Device Problem Information 2 2
Device Reprocessing Problem 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Bacterial Infection 6 6
Unspecified Tissue Injury 1 1
Nodule 1 1
Breast Cancer 1 1
Insufficient Information 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mirion Technologies (Capintec), Inc. II May-24-2024
2 Mirion Technologies (Capintec), Inc. II Feb-09-2024
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