Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EnVisio Patient Pad Transition Cushion Recalled by Elucent Medical Inc Due to There is a potential safety risk caused by...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elucent Medical Inc directly.
Affected Products
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)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 17 states: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NJ, NY, NC, ND, OH, PA, SC, WI
About Elucent Medical Inc
Elucent Medical Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report