Natus Neurology DBA Excel Tech., Ltd. (XLTEK) IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.

Recommended Action

Per FDA guidance

On 12/02/21, correction notices were mailed to customers informing them to stop using this device immediately until a solution to this issue is found. On 12/08/21, correction notices were mailed to customers informing them to follow the steps in document DOC-057825 IPELA FHD PTZ TILE KITS Correction to install Safety Wires on ceilings that meet the following structural requirements: 1) Ceilings must have existing 2' x 2' (609.6 mm x 609.6mm) ceiling tile. 2) Tile Kits ceiling tile is only compatible with a 15/16" (23.8 mm) grid tee. 3) The suspended ceiling grid must be able to support the full weight of the TILE KITS ceiling tile of 19 lbs (8.6 kg) without exceeding its loading capacity. 4) Install safety wires following instructions. Customers were asked to complete the customer reply form and to email it to FCA@Natus.com Customers with questions were provided the following phone number: 800-387-7516 Customers were asked to pass the correction notice to all those who need to be aware within their organization or to any organization where the potentially affected devices may have been transferred.