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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
2016 1 1
2017 6 6
2018 4 4
2019 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 5 5
Mechanical Problem 5 5
Loss of or Failure to Bond 2 2
Fire 1 1
Material Separation 1 1
Failure to Calibrate 1 1
Component Falling 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
No Patient Involvement 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
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