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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device battery, replacement, rechargeable
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeMOQ
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
VIDACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unintended system motion 281
Fail-safe mechanism issue 280
Device inoperable 100
Failure to charge 85
Device operates differently than expected 61
Charging issue 38
Overheating of device or device component 38
Break 17
Failure to power-up 16
Noise, Audible 14
Device displays error message 13
Battery issue 13
Crack 11
Mechanical issue 10
Device stops intermittently 6
Defective item 6
Defective component 6
Loss of power 5
Loose or intermittent connection 5
Detachment of device component 5
Mechanical jam 5
Component falling 4
No display or display failure 4
Smoking 4
Bent 3
Temperature issue 3
Torn material 2
Power source issue 2
Flare or flash 2
Material deformation 2
Connection issue 2
Premature discharge of battery 2
Corrosion 2
Failure to deliver energy 2
Device emits odor 2
Power Conditioning Issue 2
Component missing 2
Vibration 2
Failure to advance 1
Dent in material 1
Low battery 1
Difficult to position 1
Sticking 1
Slippage of device or device component 1
Moisture damage 1
Fluid leak 1
Fracture 1
Unintended head motion 1
Leak 1
Component incompatible 1
Circuit Failure 1
Detachment of device or device component 1
Device or device component damaged by another device 1
Difficult to open or close 1
Computer operating system issue 1
Failure of device to self-test 1
Total Device Problems 1075

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 3 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Pro-Dex Inc II Mar-11-2016
2 The Anspach Effort, Inc. II Jul-05-2016
3 The Anspach Effort, Inc. II Jun-15-2016

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