Elucent Medical Inc: 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

Hazard

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.

Details from the source

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 Quantity: 283 (48 units) Lot/code info: Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.