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U.S. Department of Health and Human Services

Class 2 Device Recall TruSystem

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 Class 2 Device Recall TruSystemsee related information
Date Initiated by FirmOctober 28, 2013
Date PostedNovember 18, 2013
Recall Status1 Terminated 3 on September 16, 2014
Recall NumberZ-0342-2014
Recall Event ID 66688
Product Classification Table, surgical with orthopedic accessories, manual - Product Code JEB
ProductTruSystem 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.
Code Information Item no. 1739993, All serial numbers.
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
415 Jessen Ln
Charleston SC 29492-7906
For Additional Information ContactLindsey Ronnenberg
843-534-0606
Manufacturer Reason
for Recall		The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
FDA Determined
Cause 2		Packaging
ActionTRUMPF 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 Commerce15 components
DistributionUS Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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