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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, high-voltage, x-ray, diagnostic
Regulation Description Diagnostic x-ray high voltage generator.
Product CodeIZO
Regulation Number 892.1700
Device Class 1


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 22
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 16
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 5
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Intermittent capture 1
No Information 1
Failure to capture 1
High sensing threshold 1
Dislodged or dislocated 1
Total Device Problems 5

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 1 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Oct-27-2008
2 Mallinckrodt Inc II Jun-25-2010
3 Philips Healthcare Inc. II Mar-04-2011

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