Z-0342-2014Class II

TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is...

Name: Z-0342-2014 TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is...
Creator: Trumpf Medical Systems, Inc.
Published: 2013-10-28
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2013-10-28 / Terminated / root cause: packaging

FDA source

Trumpf Medical Systems, Inc. began a recall of 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... on 2013-10-28. FDA classified it as Class II and gives the reason as "The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0342-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-28
Posted: 2013-11-18
Terminated: 2014-09-16
Recalling firm: Hill-Rom Inc.
Product: 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.
Product code: JEB Table, Surgical With Orthopedic Accessories, Manual
Reason for recall: The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Root cause tag: packaging
FDA root cause: Packaging
Action: TRUMPF sent an Urgent Safety Information letter dated October 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to inspect Leg Section One Part Light for damage to the coupler point (hook) between each case. If any damage is noticed to the coupler, they were instructed to stop use immediately and contact TRUMPF Technical Service. If they drop or collide the Leg Section One Part Light into anything then stop use immediately and contact TRUMPF Technical Service. Review the User Instruction for proper use and care of the device. The leg section should be used only as intended as part of the TRUMPF TS7000 surgical table. The intended use is to support and position the patients legs during the pre-operative and post-operative stages of surgery. The leg section should be removed during surgery. TRUMPF will be exchanging the hooks, counter plates and screws of the coupler point to increase the area that the load is distributed over. This will allow the screws securing the hood to the leg frame to withstand external forces. TRUMPF anticipates parts to be available the first week of November. TRUMPF trained technicians will complete the TRUMPF Medical Systems, Inc. for the part exchange. Completion is anticipated by November 11, 2013. Further questions please call (843) 534-0606
Quantity in commerce: 15 components
Distribution: US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
Product codes and lots: Item no. 1739993, All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0342-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0342-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code JEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)