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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table, operating-room, electrical
Regulation Description Operating tables and accessories and operating chairs and accessories.
Product CodeGDC
Regulation Number 878.4960
Device Class 1


Premarket Reviews
ManufacturerDecision
ALLEN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 1
SKYTRON
  SUBSTANTIALLY EQUIVALENT 4
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unintended movement 141
Mechanical issue 14
Detachment of device component 11
Device operates differently than expected 11
Use of Device Issue 8
Improper or incorrect procedure or method 8
Unintended system motion 8
Inadequate service 4
Device maintenance issue 3
No Information 3
Maintenance does not comply to manufacturers recommendations 3
No Known Device Problem 3
Failure to service 2
Smoking 2
Sticking 2
Malposition of device 2
Detachment of device or device component 1
Dislodged or dislocated 1
Slippage of device or device component 1
Low battery 1
Table top motion, unintended 1
Inadequate training 1
Unstable 1
Break 1
Collapse 1
Difficult to position 1
User used incorrect product for intended use 1
Replace 1
Migration of device or device component 1
Nonstandard device or device component 1
Device emits odor 1
Unintended collision 1
Component falling 1
Corrosion 1
Fire 1
Footswitch failure 1
Material frayed 1
Unintended head motion 1
Hydraulic system failure 1
Leak 1
Leak(s) from hydraulic bed system 1
Loose or intermittent connection 1
Positioning Issue 1
Material integrity issue 1
Device handling issue 1
Total Device Problems 254

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 1 0 2 0 0 1 2 1 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Berchtold Corp. II Sep-09-2013
2 Berchtold Corp. II Jun-06-2013
3 Berchtold Corp. II Apr-27-2009
4 Mizuho OSI II Feb-09-2016
5 Skytron, Div. The KMW Group, Inc II May-31-2016
6 Steris Corp II Jul-07-2009
7 Steris Corporation II Nov-07-2014
8 Steris Corporation II Sep-20-2012
9 Steris Corporation II Feb-23-2007

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