EnVisio Patient Pad Transition Cushion recall
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a…
Why was EnVisio Patient Pad Transition Cushion 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION
- Product
- EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a…
- Recalling firm
- Elucent Medical Inc
- Quantity
- 283 (48 units)
- Distribution
- US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
- Recall date
- January 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)