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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, ac-powered
Regulation Description Operating tables and accessories and operating chairs and accessories.
Product CodeFQO
Regulation Number 878.4960
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ALLEN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BERCHTOLD CORP.
  SUBSTANTIALLY EQUIVALENT 2
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
SKYTRON
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TENET MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 23
Unintended system motion 22
Device operates differently than expected 18
Table top motion, unintended 15
Unintended movement 13
Mechanical issue 9
Detachment of device component 8
Component falling 7
Improper or incorrect procedure or method 7
Device inoperable 7
Device maintenance issue 6
No Information 6
Device handling issue 6
Break 6
Component(s), worn 6
Fracture 6
Self-activation or keying 6
Drift 5
Component(s), overheating of 5
Table break 4
Sticking 4
Positioning Issue 4
Material integrity issue 3
Unstable 3
Dislodged or dislocated 3
Maintenance does not comply to manufacturers recommendations 3
Device displays error message 3
Electrical issue 3
Fluid leak 2
Collapse 2
Component(s), broken 2
Loss of power 2
Unintended head motion 2
Material deformation 2
Impedance issue 2
Malfunction 2
Other (for use when an appropriate device code cannot be identified) 2
No Known Device Problem 2
Mechanical jam 1
Power source issue 1
Noise, Audible 1
Defective component 1
Locking mechanism failure 1
Sharp/jagged/rough/etched/scratched 1
Malposition of device 1
Calibration issue 1
Detachment of device or device component 1
Heat 1
Hydraulic system failure 1
Leak 1
Normal 1
Device emits odor 1
Overheating of device or device component 1
Difficult to position 1
Failure to power-up 1
Device remains activated 1
Material separation 1
Failure to service 1
Table, tilting 1
Inadequate training 1
Burn of device or device component 1
Burrs, breakage of 1
Circuit Failure 1
Alarm, error of warning 1
Head immobilizer failure 1
Fail-safe design failure 1
Total Device Problems 259

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 5 4 4 1 4 1 2 2 4
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Berchtold Corp. II Oct-22-2015
2 Draeger Medical, Inc. II Nov-14-2013
3 IMRIS Inc II Oct-28-2014
4 Kreuzer Gmbh & Co. KG II Dec-22-2010
5 MAQUET Inc. II Nov-05-2008
6 MAQUET Inc. II Oct-16-2008
7 Maquet Cardiovascular Us Sales, Llc II Sep-07-2016
8 Maquet Cardiovascular Us Sales, Llc II Mar-03-2016
9 Maquet Cardiovascular Us Sales, Llc II Jul-17-2015
10 Maquet Medical Systems, Usa II Jul-30-2012
11 Skytron, Div. The KMW Group, Inc II May-31-2016
12 Skytron, Div. The KMW Group, Inc II Jan-14-2016
13 Smith & Nephew, Inc. Endoscopy Division II Jan-11-2012
14 Steris Corp II Jul-21-2009
15 Steris Corporation II Jul-09-2014
16 Steris Corporation II Sep-17-2012
17 Steris Corporation II Nov-23-2011
18 Steris Corporation II Dec-16-2010
19 Steris Corporation II Jun-30-2010
20 Stryker Communications Corp II Apr-06-2010
21 Stryker Communications Corp II Aug-26-2009
22 Stryker Communications Corp II May-26-2009
23 Stryker Communications Corp II Jan-16-2009
24 Stryker Communications Corp II Oct-22-2008
25 Stryker Communications Corp II Sep-18-2008
26 Stryker Communications Corp II Sep-17-2008
27 Trumpf Medical Systems, Inc. II Jan-11-2012

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