Z-0342-2014 Class II Terminated
FDA device recall Z-0342-2014 was initiated by Trumpf Medical Systems, Inc. on Oct 28, 2013 and is designated Class II. Reason for recall: The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. The recall status is terminated (terminated Sep 16, 2014). Affected quantity: 15 components.
Recall details
- Product Type
- Devices
- Report Date
- Nov 27, 2013
- Initiation Date
- Oct 28, 2013
- Termination Date
- Sep 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 components
Product 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.
Reason for recall
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Distribution pattern
US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
Code information
Item no. 1739993, All serial numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0342-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026