The following malfunctions and nonconformances were observed during Trexo lab-testing and Trexo design reviews of the device, Resulting in this voluntary device recall and proposed field correction. Electromagnetic (EM) radiation levels above threshold (Ref: IEC 60601-1-11), as observed during lab-testing contracted by Trexo. Water ingress was observed within electronics enclosures after IP22 testing, as observed during lab-testing contracted by Trexo. Recall start date: July 31, 2023
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