Drug recall
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio…
FDA recall event 95902 · Class II · Elucent Medical Inc
Key facts
| Event ID | 95902 |
|---|---|
| Recall numbers | Z-0806-2025 |
| Recalling firm | Elucent Medical Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 18, 2024 |
| Report date | Jan 15, 2025 |
| City | Eden Prairie |
| State | MN |
| Country | United States |
| FEI number | 3014653199 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: