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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 14
Mechanical issue 11
Detachment of device component 9
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
Material separation 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
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 264

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 5 4 4 1 4 1 2 2 5 0
Class III 0 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 Nov-10-2016
11 Maquet Medical Systems, Usa II Jul-30-2012
12 Skytron, Div. The KMW Group, Inc II May-31-2016
13 Skytron, Div. The KMW Group, Inc II Jan-14-2016
14 Smith & Nephew, Inc. Endoscopy Division II Jan-11-2012
15 Steris Corp II Jul-21-2009
16 Steris Corporation II Jul-09-2014
17 Steris Corporation II Sep-17-2012
18 Steris Corporation II Nov-23-2011
19 Steris Corporation II Dec-16-2010
20 Steris Corporation II Jun-30-2010
21 Stryker Communications Corp II Apr-06-2010
22 Stryker Communications Corp II Aug-26-2009
23 Stryker Communications Corp II May-26-2009
24 Stryker Communications Corp II Jan-16-2009
25 Stryker Communications Corp II Oct-22-2008
26 Stryker Communications Corp II Sep-18-2008
27 Stryker Communications Corp II Sep-17-2008
28 Trumpf Medical Systems, Inc. II Jan-11-2012

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