FDA Device recall Z-0661-2022
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
- FDA Device
- Class II
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software by Natus Neurology, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0661-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-02 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Natus Neurology |
| Distribution | US |
Product
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
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.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0661-2022%22
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