Class 2 Device Recall EnVisio Navigation System

• Date Initiated by Firm: November 18, 2024
• Date Posted: January 06, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0806-2025
• Recall Event ID: 95902
• 510(K)Number: K183400
• Product Classification: Marker, radiographic, implantable - Product Code NEU
• 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.
• Code Information: Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION
• FEI Number: 3014653199
• Recalling Firm/ Manufacturer: Elucent Medical Inc; 7480 Flying Cloud Dr Ste 110; Eden Prairie MN 55344-3720
• For Additional Information Contact: Judson Guericke; 651-7288855
• Manufacturer 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.
• FDA Determined 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 potential harm resulting from the back section disassociating from the bed frame of Skytron beds, Elucent Medical is recommending not inclining Skytron beds beyond 40 degrees with the EnVisio Patient Pad Transition Cushion present. The Patient Pad Transition Cushion can be used safely when the bed itself is not inclined to such a degree. Elucent is working on an engineering solution that will allow increased range of incline of Skytron model beds. A replacement Patient Pad Transition Cushion will be provided to you as soon as possible. Actions to be Taken by Elucent Medical: Elucent Medical will replace all Patient Pad Transition Cushions as soon as a suitable replacement is tested and available. Contact Information Please address all specific questions regarding this recall to Elucent Customer Service via telephone (844-417-1700) [Monday Friday, 7:00am 5:00 pm Central Time] or email (customerservice@elucent.com).
• Quantity in Commerce: 283 (48 units)
• Distribution: US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NEU