Class 2 Device Recall Natus NeuroworksIPELA FHD PTZ TILE KITS

• Date Initiated by Firm: December 02, 2021
• Create Date: February 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0661-2022
• Recall Event ID: 89425
• 510(K)Number: K090019 K090277
• Product Classification: Automatic event detection software for full-montage electroencephalograph - Product Code OMB
• Product: IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Natus Neurology DBA Excel Tech., Ltd. (XLTEK); 2568 Bristol Cir; Oakville Canada
• Manufacturer 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 Determined 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 FCA@Natus.com 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OMB and Original Applicant = EXCEL-TECH LTD. (XLTEK); 510(K)s with Product Code = OMB and Original Applicant = NATUS MEDICAL, INC.