As a manufacturer of medical devices, Echosens is committed to ensuring its medical devices are properly maintained and repaired during the expected service life to ensure safe and effective use. Improper service, maintenance, or remanufacturing of a medical device, or service and repairs by unqualified personnel may result in damage to a medical device, inoperability, or even adverse events. See e.g., FDA Guidance, “Remanufacturing of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff,” dated June 24, 2021.

Echosens has developed a Product Service and Recertification Program, which provides servicing and recertification services for Echosens’ medical devices. This Program is intended to repair or maintain an eligible device, return a device to its original product specifications, and/or provide device hardware and software updates. Eligible devices include those that are currently in good working order, comply with product specifications, and are within the expected service life of the device.

If you are interested in Echosens’ Product Service and Recertification Program, or would like more information, including the costs associated with Echosens’ services, please contact ESNAService@echosens.com.