Hitachi—Various Magnetic Resonance Imaging Systems: Software Error May Occur, Potentially Causing Loss of Original Images

July 3, 2013 | Risk Management News

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ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

FDA's Center for Devices and Radiological Health (CDRH) states that a software error in the systems below may cause an image in the processed database to have the same unique identifier (UID) as in the scanning dataset, potentially storing the processed image in the place of the original image, which is lost. FDA's CDRH also states that this problem may occur when simultaneously scanning a patient while processing images previously acquired from a different patient. FDA's CDRH states that the manufacturer initiated a recall by Device Correction Notice letter dated January 31, 2013. The manufacturer has not confirmed the...

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