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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device injector, contrast medium, automatic
Regulation Description Angiographic injector and syringe.
Product CodeIZQ
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEMOTO KYORINDO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 3
Self-activation or keying 3
Bubble(s) 2
Noise 2
Inaccurate flowrate 2
Detachment of device component 2
Device Issue 2
Device displays error message 1
Device operates differently than expected 1
No Known Device Problem 1
No Information 1
Break 1
Component falling 1
Computer hardware error 1
Computer software issue 1
Loose 1
Output, high 1
Program, failure to 1
Repair 1
Replace 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Component(s), broken 1
Material separation 1
Syringe, defective 1
Total Device Problems 35

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 1 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Mallinckrodt Inc II Jan-20-2012
2 Mallinckrodt Inc II Jul-21-2011
3 Mallinckrodt Inc II Aug-15-2008

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