GS70H Salus Surgical Table, Product Code 18-071-70
FDA Device Recall #Z-2470-2023 — Class II — August 1, 2023
Recall Summary
| Recall Number | Z-2470-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 1, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Skytron, LLC |
| Location | Grand Rapids, MI |
| Product Type | Devices |
| Quantity | 24 units |
Product Description
GS70H Salus Surgical Table, Product Code 18-071-70
Reason for Recall
When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, MA, MI, MO, PA, TN, TX, UT, WA, WI and the countries of Australia, New Zealand.
Lot / Code Information
Serial Numbers:SUC-20207-0002 SUC-20208-0006 SUC-20209-0010 SUC-2020X-0014 SUC-2022Z-0018 SUC-20233-0022 SUC-20207-0003 SUC-20208-0007 SUC-20209-0011 SUC-2020X-0015 SUC-2022Z-0019 SUC-20233-0023 SUC-20208-0004 SUC-20209-0008 SUC-2020X-0012 SUC-2020X-0016 SUC-2022Z-0020 SUC-20233-0024 SUC-20208-0005 SUC-20209-0009 SUC-2020X-0013 SUC-2022Z-0017 SUC-2022Z-0021 SUC-20233-0025
Other Recalls from Skytron, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2469-2023 | Class II | GS70 Salus Surgical Table, Product Code 18-070-70 | Aug 1, 2023 |
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.