Reported Jan 15, 2025 · Ongoing
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad…
Elucent Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elucent Medical Inc · 7480 Flying Cloud Dr Ste 110 · Eden Prairie, MN · 55344-3720
Is this the product you have?
- EnVisio Patient Pad Transition Cushion
- Model/Catalog NumberENVISIO-SYS
- Product DescriptionThe 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
- Lot codes and dates
- Lot CodeAll EnVisio
- Patient Pad Transition Cushions REFENVISIO-CUSHION
- Amount recalled
- 283 (48 units)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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