# FDA recall Z-0806-2025

> **Elucent Medical Inc** · Class II · device recall initiated 2024-11-18.

## 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 for recall

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.

## Distribution

US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI

## Key facts

- **Recall number:** Z-0806-2025
- **Recalling firm:** Elucent Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-18
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eden Prairie, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2025

## Citation

> AI Analytics. FDA recall Z-0806-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0806-2025. Source: US FDA. Licensed CC0.

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