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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, examination, medical, powered
Product CodeLGX
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 1 1
Unintended System Motion 1 1
Unstable 1 1
Power Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
Bruise/Contusion 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Heritage Medical Products, Inc. II Nov-08-2019
2 Maquet Cardiovascular Us Sales, Llc II Jun-04-2019
3 Oakworks Inc II Jan-13-2024
4 Oakworks Inc II Aug-25-2021
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