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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
2019 3 3
2020 1 1
2021 1 1
2022 3 3
2023 6 6
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 9 9
Detachment of Device or Device Component 6 6
Insufficient Information 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Reset 1 1
Failure to Calibrate 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
No Consequences Or Impact To Patient 2 2
Breast Cancer 1 1
No Information 1 1
Skin Discoloration 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Nodule 1 1
Unspecified Tissue Injury 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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