medical Class II Updated 2025-01-15

Elucent Medical Inc recalls EnVisio Patient Pad Transition Cushion, Model/Catalog Number

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Affected States: 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
View official government recall

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