Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Recall 89425
Description: IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Recall 89425 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0661-2022 |
| Event ID | 89425 |
| Event Description | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software |
| Product Type | Devices |
| 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 |
| Quantity | 221 |
| Recall 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. |
| Device Classification | 20220302 |
| Device Code Info | All serial numbers |
| Center Classification Date | 20220222 |
| Recall Initiation Date | 20211202 |
| Recalling Firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Initial Notification | Letter |
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