EnVisio Patient Pad Transition Cushion surgical bed frame detachment risk
Elucent Medical is recalling the EnVisio Patient Pad Transition Cushion due to a potential safety risk of the surgical bed frame's back section detaching during use. Approximately 283 units are affected across 16 U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a structural defect in surgical equipment with no reported illnesses or injuries. The potential for bed frame disassociation during surgery constitutes a risk-of-harm product where injury has not yet been reported, per the rubric criterion for Score 3.
Plain-English summary
The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System, a medical device used during surgery to detect soft tissue markers and provide real-time three-dimensional navigation. Elucent Medical Inc has issued a recall of this component due to a potential safety risk.
When the EnVisio Patient Pad Transition Cushion is used with Skytron operating room beds (models 3600, 6500, 6600, and 6700), the back section of the bed frame may physically disassociate from the frame during use. This defect could compromise the stability of the surgical bed during procedures.
Approximately 283 units have been distributed to healthcare facilities across 16 U.S. states: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Carolina, and Wisconsin. All affected units are identified by the lot code ENVISIO-CUSHION. As of the recall notice, no injuries or illnesses have been reported.
Healthcare facilities using the affected equipment should discontinue use of the EnVisio Patient Pad Transition Cushion with the affected Skytron bed models and contact Elucent Medical Inc for replacement or repair instructions.
The recalled product
- 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)…
- Manufacturer
- Elucent Medical Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION
Distribution
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