Elucent Medical recalls EnVisio Patient Pad Transition Cushions due to potential disconnection from operating room bed frames during surgery, which could cause patient injury.
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.
Elucent Medical is recalling EnVisio Patient Pad Transition Cushions because they can become physically disconnected from operating room bed frames during surgery. This disconnection risk could lead to patient injury if the cushion slips off the bed frame while the patient is being moved.
The cushion can physically separate from the bed frame during surgery. This disconnection could cause the cushion to move unexpectedly, potentially leading to patient injury if the patient is being moved or repositioned.
Surgical teams using EnVisio Patient Pad Transition Cushions with Skytron model 3600, 6500, 6600, or 6700 operating room beds are most at risk. Patients undergoing surgery with this specific cushion setup could be injured if the cushion becomes disconnected.
Check for the EnVisio Patient Pad Transition Cushion with model/catalog number ENVISIO-SYS. This product is used with Skytron operating room beds (models 3600, 6500, 6600, 6700) in surgical settings.
Inspect the cushion to ensure it remains securely attached to the bed frame during use. If it becomes loose, stop using it immediately.
The recall states there is a potential safety risk, so it is not safe to use without checking for disconnection.
Skytron model series 3600, 6500, 6600, and 6700 operating room beds.
Look for the EnVisio Patient Pad Transition Cushion with model/catalog number ENVISIO-SYS.
We’ve drafted a message you can send Elucent Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0806-2025 — Elucent Medical Elucent Medical Hello, I own a Elucent Medical that is covered by recall Z-0806-2025 from Elucent Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
