Baxter Operating Table TruSystem 7000, Product code REF 1841046
FDA Device Recall #Z-0211-2025 — Class II — September 19, 2024
Recall Summary
| Recall Number | Z-0211-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 19, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 397 units |
Product Description
Baxter Operating Table TruSystem 7000, Product code REF 1841046
Reason for Recall
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
UDI/DI 00887761968714, All Serial Numbers
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| Z-1121-2026 | Class II | SIGMA Spectrum Infusion Pump, Model/Catalog Num... | Nov 28, 2025 |
| Z-0847-2026 | Class II | Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalo... | Oct 28, 2025 |
| Z-0233-2026 | Class II | Oral Probe (Product code 02893-000), accessory ... | Sep 17, 2025 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
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.