Z-0806-2025 Class II Ongoing
FDA device recall Z-0806-2025 was initiated by Elucent Medical Inc on November 18, 2024 and is designated Class II. 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 EnVis… The recall status is ongoing. Affected quantity: 283 (48 units).
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- November 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 283 (48 units)
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.
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 Pattern
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
Code Information
Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION