# FDA recall Z-0661-2022

> **Natus Neurology DBA Excel Tech., Ltd. (XLTEK)** · Class II · device recall initiated 2021-12-02.

## 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.

## 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

## Key facts

- **Recall number:** Z-0661-2022
- **Recalling firm:** Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-02
- **Report date:** 2022-03-02
- **Termination date:** 2024-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oakville, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0661-2022

## Citation

> AI Analytics. FDA recall Z-0661-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0661-2022. Source: US FDA. Licensed CC0.

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