FDA recall Z-0661-2022

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, MI, MA, NE, OK, WV, MO, VA, CT, IN, HI, PA, CA, MD, OH, CO, SC, PR, NV, NJ, OR, LA, DC, NC and the countries of Nepal, Viet Nam, Canada, Saudi Arabia, Indonesia, Germany, Korea, Republic of

Key facts

Status
Terminated
Initiation date
2021-12-02
Report date
2022-03-02
Termination date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakville, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0661-2022