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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device support, patient position
Regulation Description Patient position support.
Product CodeCCX
Regulation Number 868.6820
Device Class 1


Premarket Reviews
ManufacturerDecision
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Dent in material 3
Patient-device incompatibility 2
Material deformation 2
Not Applicable 1
No code available 1
Component or accessory incompatibility 1
Device operates differently than expected 1
Failure to obtain samples 1
Accessory incompatible 1
Break 1
Product quality issue 1
Improper or incorrect procedure or method 1
Unknown (for use when the device problem is not known) 1
Malfunction 1
Total Device Problems 18

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

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems, Inc. II Jan-11-2012
2 Allen Medical Systems, Inc. II Aug-20-2008
3 Covidien LLC II Jul-07-2014

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