Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0661-2022

December 02, 2021

Class II

Product summary

Firm
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Event
Event 89425
Status
Terminated
Classification
Class II
Quantity
221
Official record key
device-enforcement:Z-0661-2022

Official wording

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.