Recall archive / FDA device enforcement
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pa... — FDA record Z-0806-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- 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.
- Classification
- Class II
- Recalling firm
- Elucent Medical Inc
- Quantity
- 283 (48 units)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0806-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 15, 2025
- Recall initiation date
- Nov 18, 2024
- Center classification date
- Jan 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.