FDA Medical devices recall · January 15, 2025

EnVisio Patient Pad Transition Cushion, Model recall

Read the official FDA notice ↗

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.

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

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

States: Arizona California Colorado Connecticut Florida Georgia Illinois Kentucky Minnesota North Carolina North Dakota New Jersey New York Ohio Pennsylvania South Carolina Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0806-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.