EASYACCESS

Additional Manufacturer Narrative

EVALUATION RESULT: THE SYSTEM IS CURRENTLY STILL BEING INVESTIGATED FOR ROOT CAUSE. CONCLUSIONS: THE SYSTEM IS CURRENTLY STILL BEING INVESTIGATED FOR THE EXACT ROOT CAUSE AND WHEN COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO FDA.

Description of Event or Problem

THE HOSP RADIOLOGISTS ARE CONCERNED ABOUT THE MAGNETIC RESONANCE (MR) IMAGES COMING FROM THE EASYACCESS, PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS). THE WINDOW AND CENTER LEVELING WHICH CONTROLS THE IMAGE CONTRAST AND BRIGHTNESS IS BEING RANDOMLY SET INCORRECTLY BY PACS OR MR IMAGES. ALSO, SOME OF THE PACS DERIVED IMAGES CANNOT BE LEVELED AT ALL. THE RADIOLOGISTS FEEL THIS LIMITES THEIR ABILITIES TO MAKE SAFE DIAGNOSTIC MR IMAGE INTERPRETATIONS. NO PTS HAVE BEEN MISDIAGNOSED OR INJURED IN REGARDS OF THIS ISSUE.