Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, Tru...
FDA Device Recall #Z-0759-2016 — Class II — January 19, 2016
Recall Summary
| Recall Number | Z-0759-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 19, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Trumpf Medical Systems, Inc. |
| Location | Charleston, SC |
| Product Type | Devices |
| Quantity | 1284 affected units |
Product Description
Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.
Reason for Recall
Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
Distribution Pattern
Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.
Lot / Code Information
Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175 101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652.
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.