Accriva—AVOXimeter 1000E Instruments: Diagnostic Mode May Be Enabled, Potentially Leading to Users Mistakenly Unlocking Features

May 25, 2016 | 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 May 13, 2016, Technical Notification letter submitted by ECRI Institute member hospitals, Accriva states that the above instruments may have been serviced and shipped with the diagnostic mode enabled. Accriva also states that with the diagnostic mode enabled, users could mistakenly unlock features in the instrument software through a specific sequence of keystrokes and that if these features are altered, there is potential for erroneous results to be displayed. Accriva further states that the potential to alter these features is remote, and that instruments in diagnostic mode perform according to the firm's specifications and all data generation is equivalent to those instruments properly set to user mode. Accriva also states that it has received no reports of injuries or harm associated with this problem. The manufacturer has not confirmed the...

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