Z-0661-2022 Class II Terminated
FDA device recall Z-0661-2022 was initiated by Natus Neurology DBA Excel Tech., Ltd. (XLTEK) on December 2, 2021 and is designated Class II. 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 fram… The recall status is terminated (terminated September 18, 2024). Affected quantity: 221.
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2022
- Initiation Date
- December 2, 2021
- Termination Date
- September 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 221
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.
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
Code Information
All serial numbers