Natus Neurology DBA Excel Tech., Ltd. (XLTEK): Medical Device Recall in 2022 - (Recall #: Z-0661-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 2, 2021

Date Posted: March 2, 2022

Recall Number: Z-0661-2022

Event ID: 89425

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.

Status: Terminated

Product Quantity: 221

Code Information:

All serial numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated