Siemens—ARTIS Q and ARTIS Pheno Systems: Temperature Control Unit May Be Incorrectly Configured
August 8, 2018 | Risk Management News
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In a July 27, 2018, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Siemens states that the temperature control unit on the above systems may be incorrectly configured, potentially causing the temperature of the detector to fall out of its designed working range. Siemens also states that this problem may occur when the unit is powered down for long periods. Siemens further states that if this problem occurs and the temperature is not kept at a constant level, the system may take longer to start up (up to 90 minutes) until it is ready for clinical use, potentially causing procedure delay or necessitating transfer of an emergency treatment to an alternative system. The manufacturer has not confirmed the...