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

FDA Device Recall #Z-0342-2014 — Class II — October 28, 2013

Recall Summary

Recall Number Z-0342-2014
Classification Class II — Moderate risk
Date Initiated October 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Trumpf Medical Systems, Inc.
Location Charleston, SC
Product Type Devices
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.

Lot / Code Information

Item no. 1739993, All serial numbers.

Other Recalls from Trumpf Medical Systems, Inc.

Recall # Classification Product Date
Z-0824-2018 Class II Camera System, Television, Surgical without aud... Dec 15, 2017
Z-0391-2017 Class II OR Table, Top U26 H V, Model # 1909793; OR Tabl... Oct 25, 2016
Z-0042-2017 Class II Floor Mounting Column TS 7500 U, Material Numbe... Jul 10, 2016
Z-0043-2017 Class II Operating Table TruSystem 7000 U, Material Numb... Jul 10, 2016
Z-0040-2017 Class II Mobile Column TruSystem 7500, Material Number 1... Jul 10, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.