Recall Z-0661-2022 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
| Date | Dec 2, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | On 12/02/21, correction notices were mailed to customers informing them to stop using this device immediately until a solution to this issue is found. On 12/08/21, correction notices were mailed to customers informing them to follow the steps in document DOC-057825 IPELA FHD PTZ TILE KITS Correction to install Safety Wires on ceilings that meet the following structural requirements: 1) Ceilings must have existing 2' x 2' (609.6 mm x 609.6mm) ceiling tile. 2) Tile Kits ceiling tile is only compatible with a 15/16" (23.8 mm) grid tee. 3) The suspended ceiling grid must be able to support the f |
| Quantity | 221 |
| 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 |
| FDA record | Open on fda.gov |