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EnVisio Patient Pad Transition Cushion, Model/Catalog… recallZ-0806-2025 · Elucent Medical Inc · initiated Nov 18, 2024

Class II Open, Classified All recalls posted in January 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Elucent Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

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]).

Recall details

Recall number
Z-0806-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Nov 18, 2024
Posted by the FDA
Jan 6, 2025
Recalling firm
Elucent Medical Inc
Quantity
283 (48 units)
Product code
NEU
FDA submissions
K183400
Distribution
US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI

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.

Code information (models, lots, serial numbers)

Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION

Other devices under the same FDA submission

3 devices cleared under K183400 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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