IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Reported: March 2, 2022 Initiated: December 2, 2021 #Z-0661-2022
Product Description
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.
Details
- Recalling Firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Units Affected
- 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
- Location
- Oakville
Frequently Asked Questions
What product was recalled? ▼
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software. Recalled by Natus Neurology DBA Excel Tech., Ltd. (XLTEK). Units affected: 221.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2022. Severity: Moderate. Recall number: Z-0661-2022.
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