Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0661-2022 — IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

U.S. FDA — Device Enforcement · Canada · 2021-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0661-2022
Date of alert
2021-12-02
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.