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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
Device table, radiologic
Regulation Description Radiologic table.
Product CodeKXJ
Regulation Number 892.1980
Device Class 2

Device Problems
Fluid Leak 6
Unintended Movement 5
Mechanical Problem 3
Hydraulic System 3
Table 3
Unintended System Motion 2
Break 2
Controller 1
Loose or Intermittent Connection 1
Detachment of Device or device Component 1
Hydraulic Bed System 1
Total Device Problems 28

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Mar-13-2018
2 GE Healthcare, LLC II Jun-10-2019
3 Villa Radiology Systems LLC II Jan-20-2017
4 Villa Radiology Systems LLC II Mar-06-2015
5 Villa Sistemi Medicali S.P.A. II Dec-31-2019
6 Villa Sistemi Medicali S.P.A. II Mar-09-2017

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