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.
This recall is currently active, issued January 6, 2025. It was issued by Elucent Medical Inc.
- Company
- Elucent Medical Inc
- Recall Initiated
- November 18, 2024
- Posted
- January 6, 2025
- Recall Number
- Z-0806-2025
- Quantity
- 283 (48 units)
- Firm Location
- Eden Prairie, MN
- Official Source
- View on FDA website ↗
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
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
Lot / Code Info
Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION
Root Cause
Device Design
Action Taken
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).