TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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 system motion	8
Device operates differently than expected	5
Sticking	2
Malposition of device	2
Mechanical issue	2
Migration of device or device component	1
Nonstandard device or device component	1
Device emits odor	1
Difficult to position	1
Replace	1
Slippage of device or device component	1
Smoking	1
Collapse	1
Detachment of device component	1
Corrosion	1
Footswitch failure	1
Unintended head motion	1
Hydraulic system failure	1
Leak	1
Leak(s) from hydraulic bed system	1
Table top motion, unintended	1
Improper or incorrect procedure or method	1
Unintended movement	1
No Information	1
Total Device Problems	38

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	2	0	0	1	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Berchtold Corp.	II	Apr-27-2009
2	Steris Corp	II	Jul-07-2009
3	Steris Corporation	II	Sep-20-2012
4	Steris Corporation	II	Feb-23-2007