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Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Recall 89425

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

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Recall 89425 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0661-2022
Event ID89425
Event DescriptionIPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Product TypeDevices
DistributionWorldwide 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
Quantity221
Recall ReasonTile 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.
Device Classification20220302
Device Code InfoAll serial numbers
Center Classification Date20220222
Recall Initiation Date20211202
Recalling FirmNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
Initial Notification Letter
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