FDA-Device2013-11-27Class II

TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is u

Trumpf Medical Systems, Inc.
Hazard

The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.

Sold states
US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
Affected count
15 components
Manufactured in
415 Jessen Ln, Charleston, SC, United States
Products
TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2014

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