Excel Medical Electronics LLCDecember 19, 2025

FDA 483 - Excel Medical Electronics LLC - December 19, 2025

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Record Details

Excel Medical Electronics LLC, a manufacturer of medical electronics, was inspected and cited for deficiencies in its quality system. The inspection revealed inadequate procedures for design verification, specifically regarding the Wave Clinical Platform Software, and an insufficient risk analysis that failed to include pertinent risks and mitigation actions related to software configuration. These issues indicate a need for improved quality system controls.

Company: Excel Medical Electronics LLC
Inspection Date: December 19, 2025
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Gisselle I. Sensebe

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ID · 74e30dd9-54c4-41d2-8a48-48e4fc7f0920