CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
The EnVisio Patient Pad Transition Cushion is a component recalled
Elucent Medical is recalling The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation, distributed in 17 states. The recall was initiated on 18 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0806-2025
- FDA event ID
- 95902
- Recalling firm
- Elucent Medical, Eden Prairie, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Nov 2024
- FDA classified
- 6 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2024 | Recall initiated by company | |
| 6 Jan 2025 | Classified by FDA | +49 days |
| 15 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisKentuckyMinnesotaNorth CarolinaNorth DakotaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION
Where was it sold?
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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