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FusionMAX
SURGIX MEDICAL LLC · Model 30427 · UDI-DI 00840343716776
10
510(k) clearances
635
Adverse events (3 deaths)
41
Recalls
24
Facilities
Description
Rope Traction Assembly- metal pulley device designed to be used in cervical spine procedures. To be used in conjunction with rope and surgical weights. Attaches to head of surgical table with mounting assembly
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.