Eakin Surgical Limited, ESL-2301, Diathermy Suction

Testing of the Diathermy Suction Devices has revealed non-compliance with IEC 60601-2-2-2017 standard: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.  A health hazard assessment has been conducted and has determined that the risk of harm to patient or user is remote. To date there have been no complaints or adverse events reported related to this potential nonconformity and Eakin Surgical do not believe that it is likely to lead to any patient or user injury.