IPELA FHD PTZ TILE KITS with Axis cameras used in combination with… — Class II medical device recall Z-0661-2022
Terminated recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), reported 2022-03-02, distributed nationwide. Tile kits that allow one to install and situate a video camera within a patient environment are not fitting pr
| Recall number | Z-0661-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK), Oakville, Canada |
| Recall initiated | 2021-12-02 |
| Classified | 2022-02-22 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, ID, KR, NP, SA, VN |
| Quantity | 221 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0661-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.