Philips—Azurion Systems: Screws May Loosen, Potentially Causing C-Arm to Rotate Freely Over "Roll" Movement
March 18, 2020 | Risk Management News
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In a February 26, 2020, Urgent Medical Device Correction letter submitted by an ECRI member hospital, Philips states that no torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor of the above systems. Philips also states that if the torque is too low, the movement of the system may cause stress on the screws, potentially resulting in the screws becoming loose. Philips further states that if this occurs, the C-arm may rotate freely over the "roll" movement and the system will be unusable, potentially leading to a delay in treatment. Philips states that uncontrolled movement of the C-arm may result in collision and/or entrapment. The manufacturer has not confirmed the...