Elucent Medical Inc: Device Recall
Recall #Z-0806-2025 · 11/18/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0806-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Elucent Medical Inc
- Status
- Ongoing
- Date Initiated
- 11/18/2024
- Location
- Eden Prairie, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 283 (48 units)
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.
Product Description
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.
Distribution Pattern
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.