Elucent Medical Inc recalls EnVisio Patient Pad Transition Cushion

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.

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).

• FDA enforcement recordOfficial FDA database entry for Z-0806-2025
• FDA 510(k) clearance · K183400The device's official FDA premarket clearance record
• FDA device classification · NEUOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Elucent Medical IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.