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PAD, TABLE, 5855 ORTHO TRAUMA TOP
MIZUHO ORTHOPEDIC SYSTEMS, INC. · Model 5855-7297 · UDI-DI 00842430100512
10
510(k) clearances
635
Adverse events (3 deaths)
41
Recalls
24
Facilities
Description
This pad is designed for use with the Mizuho OSI Orthopedic Trauma Tops. Dimensions: 30.9x19.5x3 inches. Made with Tempur-Pedic® Medical materials
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.