Class II — Elucent Medical Inc
| Recalling firm | Elucent Medical Inc. |
|---|---|
| Registered facility | ELUCENT MEDICAL INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System. |
| Product | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery. |
| Quantity | 283 (48 units) |
| Distribution | US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI |
| Initiated | 2024-11-18 |
| Classified | 2025-01-06 |
| Recall number | Z-0806-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Elucent Medical Inc (Z-0806-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95902/
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