Recall Z-0806-2025 ยท NEU Marker, Radiographic, Implantable
Elucent Medical Inc
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.
| Date | Jan 6, 2025 (initiated Nov 18, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | An "Urgent Medical Device Recall" letter dated 11/18/24 was sent to customers. How to Recognize That the Device May Fail: An audible sound is made by the compression of the EnVisio Patient Pad Transition Cushion prior to the back section disassociation from the bed frame. We are aware of one product event associated with one complaint involving this issue. Component Which is the Subject of This Recall: The subject of this recall is the EnVisio Patient Pad Transition Cushion as it pertains to the inclining of Skytron Beds greater than 40 degrees. Actions to be Taken by the Customer: Due to p |
| Quantity | 283 (48 units) |
| Distribution | US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183400 | EnVisio Navigation Sytem Elucent Medical, Inc., Mar 22, 2019 |