Elucent Medical Inc is recalling 283 EnVisio Patient Pad Transition Cushions (Model ENVISIO-SYS) used with the EnVisio Navigation System. The recall was issued because the cushions can cause the back section of specific Skytron operating room beds (models 3600, 6500, 6600, and 6700) to physically detach from the bed frame during surgery. No injuries have been reported to date, but the mechanical failure poses a significant safety risk during medical procedures.
The cushion may cause the back section of the surgical bed to disconnect from its frame during use. This detachment could lead to patient instability or injury during surgical navigation and procedures.
Component of the EnVisio Navigation System; used with Skytron model series 3600, 6500, 6600 and 6700 operating room beds.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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