Recall Z-0661-2022— Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Name: FDA recall Z-0661-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-02

Class II · Terminated

Class II FDA medical device recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), initiated 2021-12-02, terminated 2024-09-18. It names 2 FDA 510(k) clearances: K090277, K090019. Product: IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software. Reason: 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..

Recalling firm: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Classification: Class II
Status: Terminated
Initiated: 2021-12-02
Terminated: 2024-09-18
Firm location: Oakville, Canada

510(k) clearances named in this recall

2 on FDA's record

K090277 — NATUS SLEEPWORKS, MODEL 104017Excel-Tech Ltd. (Xltek)·cleared 2011-04-19
K090019 — NATUS NEUROWORKS, MODEL 104196Natus Medical, Inc.·cleared 2010-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.