Philips—BrightView and Precedence Systems: Collimator May Fall from Cart or Detector Head
January 10, 2018 | Risk Management News
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In a December 5, 2017, Urgent Field Safety Notice Medical Device Correction letter submitted by ECRI Institute member hospitals, Philips states that the collimator may fall from the detector head or collimator cart during collimator exchange on the above systems. Philips also states that the alignment of the collimator cart and detectors is such that a collimator drops to the floor beside the collimator cart. In some cases, the collimator may be partially supported by the cart (e.g., leaning against the cart), and in others, it may fall/slide all the way to the floor. Philips further states that this problem may cause harm to the user if the user is next to or near the collimator cart when the collimator falls. Philips states that this problem may also lead to the patient requiring an additional injection of radiopharmaceutical, if the system becomes unusable because of collimator failure, the patient has already received their injection, and the acquisition is unable to be completed. The manufacturer has not confirmed the...