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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, ceiling mounted
Regulation Description Surgical lamp.
Product CodeFSY
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
ALM
  SUBSTANTIALLY EQUIVALENT 3
BERCHTOLD CORP.
  SUBSTANTIALLY EQUIVALENT 11
BURTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DR. MACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GETINGE
  SUBSTANTIALLY EQUIVALENT 2
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAVIG GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 1
NUVO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKYTRON
  SUBSTANTIALLY EQUIVALENT 6
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
TRUMPF MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 226
Component falling 186
Dislodged or dislocated 43
Other (for use when an appropriate device code cannot be identified) 39
Detachment of device or device component 31
Material separation 30
Material integrity issue 29
Device Issue 27
Flaked 25
Material disintegration 24
Mechanical issue 23
Use of Device Issue 21
Break 19
Crack 16
Component missing 16
Device operates differently than expected 16
Smoking 15
Corrosion 13
Fracture 11
Maintenance does not comply to manufacturers recommendations 11
Misassembled 9
Component(s), broken 8
Pitted 8
Component(s), overheating of 7
Degraded 7
Device maintenance issue 7
Electrical issue 7
Disinfection, inadequate/improper 6
Material fragmentation 6
Metal shedding debris 6
Fire 5
Migration of device or device component 5
Connector pin failure 5
Instruction for use issue 4
Loose or intermittent connection 4
Material erosion 4
Difficult to position 4
Device emits odor 4
Output energy incorrect 4
No Known Device Problem 4
Buckled material 4
Unintended movement 3
Positioning Issue 3
Temperature issue 3
Material deformation 3
Installation-related problem 3
Unintended collision 3
Loss of power 3
Slippage of device or device component 2
Unstable 2
Improper or incorrect procedure or method 2
Spark 2
Dislodged 2
Burn of device or device component 2
No Information 2
Torn material 1
Unauthorized access to computer system 1
Light interference 1
Optical issue 1
Moisture or humidity problem 1
Unintended arm motion 1
Component(s), worn 1
Computer failure 1
Disassembly 1
Disconnection 1
Heat 1
Loose 1
Melted 1
Normal 1
Malfunction 1
Structural problem 1
Arcing 1
Fuse, blown 1
Device or device component damaged by another device 1
Device unsafe to use in environment 1
Environmental control or utility issue 1
Failure to shut off 1
Inadequate lighting 1
Failure to osseointegrate 1
Sticking 1
Failure to service 1
Failure to power-up 1
Product quality issue 1
Repair 1
No device output 1
Total Device Problems 1004

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 2 1 2 5 2 2 6 2 3
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beaver-Visitec International Inc. II Jun-15-2015
2 Centurion Medical Products Corporation II Jul-20-2016
3 Covidien LLC II Jul-20-2015
4 MAQUET Inc. II Nov-12-2009
5 Maquet Cardiovascular Us Sales, Llc II Jul-07-2015
6 Maquet Medical Systems USA II Jun-06-2014
7 Resource Optimization & Innovation Llc II Oct-07-2015
8 Siemens Medical Solutions USA, Inc II Dec-12-2012
9 Steris Corporation II Jun-23-2014
10 Steris Corporation II Apr-05-2011
11 Stryker Communications II Mar-10-2017
12 Stryker Communications Corp II Jan-26-2012
13 Stryker Communications Corp II Oct-28-2011
14 Stryker Communications Corp II May-21-2010
15 Stryker Communications, Inc. II Jan-09-2013
16 Trumpf Medical Systems, Inc. II Dec-31-2015
17 Trumpf Medical Systems, Inc. II Aug-07-2015
18 Trumpf Medical Systems, Inc. II Dec-12-2013
19 Trumpf Medical Systems, Inc. II Oct-18-2012
20 Trumpf Medical Systems, Inc. II Sep-05-2012
21 Trumpf Medical Systems, Inc. II Feb-13-2012
22 Trumpf Medical Systems, Inc. II Apr-01-2009
23 Windstone Medical Packaging, Inc. II Apr-11-2017
24 Windstone Medical Packaging, Inc. II Feb-28-2017
25 Windstone Medical Packaging, Inc. II Oct-20-2016

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