Philips—Xcelera Connect Software Used with Xcelera Cardiac Image Processing Systems: External Information System Diagnostic Information May Be Incomplete

June 27, 2012 | 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.

In a June 1, 2012, Urgent Field Safety Notice letter submitted by an ECRI Institute member hospital, Philips states that if the user enters a carriage return in the free text option of the interpretation summary field of the below-listed systems to enter a diagnostic outcome, the software below may send the text to the external information system, potentially making the text truncated and not visible to the user. This problem may result in missing diagnostic information and may lead to a misdiagnosis and incorrect treatment if the incorrect or incomplete text is used as the sole basis for diagnosis. Philips states that the correct and complete information is still available within the system. The manufacturer has not confirmed the...

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