Z-0806-2025Class II

EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio...

Name: Z-0806-2025 EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio...
Creator: Elucent Medical Inc
Published: 2024-11-18
License: https://open.fda.gov/license/

Elucent Medical Inc / initiated 2024-11-18 / Open, Classified / root cause: design

FDA source

Elucent Medical Inc began a recall of EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the... on 2024-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0806-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-18
Posted: 2025-01-06
Recalling firm: Elucent Medical Inc
Product: 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.
Product code: NEU Marker, Radiographic, Implantable
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.
Root cause tag: design
FDA root cause: Device Design
Action: An "Urgent Medical Device Recall" letter dated 11/18/24 was sent to customers. How to Recognize That the Device May Fail: An audible sound is made by the compression of the EnVisio Patient Pad Transition Cushion prior to the back section disassociation from the bed frame. We are aware of one product event associated with one complaint involving this issue. Component Which is the Subject of This Recall: The subject of this recall is the EnVisio Patient Pad Transition Cushion as it pertains to the inclining of Skytron Beds greater than 40 degrees. Actions to be Taken by the Customer: Due to potential harm resulting from the back section disassociating from the bed frame of Skytron beds, Elucent Medical is recommending not inclining Skytron beds beyond 40 degrees with the EnVisio Patient Pad Transition Cushion present. The Patient Pad Transition Cushion can be used safely when the bed itself is not inclined to such a degree. Elucent is working on an engineering solution that will allow increased range of incline of Skytron model beds. A replacement Patient Pad Transition Cushion will be provided to you as soon as possible. Actions to be Taken by Elucent Medical: Elucent Medical will replace all Patient Pad Transition Cushions as soon as a suitable replacement is tested and available. Contact Information Please address all specific questions regarding this recall to Elucent Customer Service via telephone (844-417-1700) [Monday Friday, 7:00am 5:00 pm Central Time] or email ([email protected]).
Quantity in commerce: 283 (48 units)
Distribution: US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI
Product codes and lots: Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0806-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0806-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-06

Product code NEU

K183400Class IIEnVisio Navigation SytemElucent Medical, Inc. / cleared 2019-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)