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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, film marking, radiographic
Product CodeJAC
Regulation Number 892.1640
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 1 1
2017 1 1
2018 4 4
2019 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Signal Artifact/Noise 5 5
Nonstandard Device 3 3
Peeled/Delaminated 1 1
Material Separation 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Device Markings/Labelling Problem 1 1
Device Handling Problem 1 1
Break 1 1
Display or Visual Feedback Problem 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Code Available 4 4
No Information 3 3
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beekley Corporation II Aug-16-2018
2 Beekley Corporation III Jun-27-2017
3 Beekley Corporation II Jul-31-2012
4 GE Healthcare, LLC II Feb-27-2013
5 GE Healthcare, LLC II Feb-26-2013
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