EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad
Summary
The FDA issued a Class II for EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Produ by Elucent Medical Inc. Reason: 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.
Details
Source
Device Recall
External ID
Z-0806-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION
Quantity Affected: 283 (48 units)
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.
Distribution
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-18
Company
Eden Prairie, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Elucent Medical Inc has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elucent Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elucent Medical Inc have FDA actions?
Elucent Medical Inc has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0806-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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