The issue found can cause the device to overheat during operation if the circulation pressure calibration was not performed or been performed incorrect and the low-pressure alarm is not triggered. The scope of this action is the electrical heated 88-5 washer disinfectors. Justification: the construction on steam heated devices is different and the heating elements cannot be overheated. This field action is initiated to verify that the circulation pressure in standby mode reads 0.0 kPa. If the value deviates from 0.0 kPa, the device must be recalibrated by a qualified technician to ensure safe continued clinical use. Recall start date: August 21, 2025
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