Use caution Medical device recall · FDA · Published December 2, 2021

Natus Neurology IPELA FHD PTZ Tile Kits Recall: Ceiling Tile Risk

Natus Neurology recalls IPELA FHD PTZ Tile Kits with Axis cameras used in sleep monitoring software. Ceiling tiles may fall causing injury. Check serial numbers for affected units.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0661-2022Medical device Natus Neurology ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmNatus Neurology DBA Excel Tech., Ltd. (XLTEK)2568 Bristol Cir · Oakville, Canada

✎ GovInfoNow plain-language explainer

Natus Neurology is recalling IPELA FHD PTZ Tile Kits that use Axis cameras with their sleep monitoring software. The kits may not fit properly in some ceiling tile grids, causing tiles to fall and potentially injure patients or users. Read more at govinfonow.com/recall/61477-natus-neurology-ipela-fhd-ptz-tile-kits-recall-ceiling-tile.

Source Summary by GovInfoNow · govinfonow.com/recall/61477-natus-neurology-ipela-fhd-ptz-tile-kits-recall-ceiling-tile · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0661-2022

Cite this page

“Natus Neurology IPELA FHD PTZ Tile Kits Recall: Ceiling Tile Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61477-natus-neurology-ipela-fhd-ptz-tile-kits-recall-ceiling-tile. Based on FDA recall #Z-0661-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0661-2022%22&limit=1).

The FDA announced on December 2, 2021, that Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling IPELA FHD PTZ TILE KITS with Axis cameras used with Natus Neuroworks/Sleepworks software. The tile kits may not fit properly in thinner ceiling grid frames, causing tiles to fall and create a safety risk.

How to tell if you have it

Brand: Natus Neurology
Product: IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Serial numbers: All serial numbers
Quantity: 221 units
Distribution: US Nationwide (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 countries including Nepal, Viet Nam, Canada, Saudi Arabia, Indonesia, Germany, Korea, Republic

The hazard

According to the FDA, the tile kits 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.

Context

GovInfoNow's records show Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has had five other recalls since May 15, 2018, including a June 18, 2025 recall for left side labeling errors on Brain Monitor Breakout Boxes and a May 7, 2025 recall regarding backward electrode labels on OBM DAB Digital Acquisition Boxes. Other recent recalls of similar products include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Stryker CHROMOPHARE Softlit Ring Surgical Light Recall (February 23, 2026), and the Canon Alphenix INFX-8000C X-ray System Recall (December 19, 2025).

How to tell if you have this one

Check if your unit has the IPELA FHD PTZ Tile Kit with Axis cameras used with Natus Neuroworks/Sleepworks software. All units have serial numbers.

Brand
Natus Neurology
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify your unit's serial number to confirm it is affected by this recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 24 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia, West Virginia.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Dec 2, 2021Firm started the recall
Feb 22, 2022FDA classified it Class II
Mar 2, 2022Published in FDA’s Enforcement Report
Sep 18, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Natus Neurology recalls

Link to this recall

<a href="https://govinfonow.com/recall/61477-natus-neurology-ipela-fhd-ptz-tile-kits-recall-ceiling-tile">Natus Neurology IPELA FHD PTZ Tile Kits Recall: Ceiling Tile Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0661-2022 (December 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0661-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.