FDADecember 2, 2021device

IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

natus neurology dba excel tech ltd xlteknatusnatus neurology

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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