Elucent Medical Inc: Medical Device Recall in 2025 - (Recall #: Z-0806-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 18, 2024

Date Posted: January 15, 2025

Recall Number: Z-0806-2025

Event ID: 95902

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.

Status: Ongoing

Product Quantity: 283 (48 units)

Code Information:

Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION

Distribution Pattern:

US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI

Voluntary or Mandated:

Voluntary: Firm initiated