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.
Enforcement
- Recall Number
- Z-0342-2014
- Event ID
- 66688
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Trumpf Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2013
- Initiation Date
- October 28, 2013
- Classification Date
- November 18, 2013
- Termination Date
- September 16, 2014
- Address
- 415 Jessen Ln, Charleston, SC, 29492-7906, United States
Description
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.
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Item no. 1739993, All serial numbers.
US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
15 components