Z-0661-2022Class II

IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

Name: Z-0661-2022 IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Creator: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Published: 2021-12-02
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2021-12-02 / Terminated

FDA source

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) began a recall of IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software on 2021-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0661-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-02
Posted: 2022-02-22
Terminated: 2024-09-18
Recalling firm: Natus Medical Incorporated
Product: IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Product code: OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
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.
FDA root cause: Process change control
Action: On 12/02/21, correction notices were mailed to customers informing them to stop using this device immediately until a solution to this issue is found. On 12/08/21, correction notices were mailed to customers informing them to follow the steps in document DOC-057825 IPELA FHD PTZ TILE KITS Correction to install Safety Wires on ceilings that meet the following structural requirements: 1) Ceilings must have existing 2' x 2' (609.6 mm x 609.6mm) ceiling tile. 2) Tile Kits ceiling tile is only compatible with a 15/16" (23.8 mm) grid tee. 3) The suspended ceiling grid must be able to support the full weight of the TILE KITS ceiling tile of 19 lbs (8.6 kg) without exceeding its loading capacity. 4) Install safety wires following instructions. Customers were asked to complete the customer reply form and to email it to [email protected] Customers with questions were provided the following phone number: 800-387-7516 Customers were asked to pass the correction notice to all those who need to be aware within their organization or to any organization where the potentially affected devices may have been transferred.
Quantity in commerce: 221
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
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0661-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0661-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-22

Product code OMB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)