Smiths—Medfusion 4000 Syringe Infusion Pumps with Firmware Version 1.7.0: Firmware Anomaly May Cause Loss of Primary Battery Alarm Functionality and Interrupt Therapy

December 18, 2019 | 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 Device Alerts. For more information contact us at clientservices@ecri.org.

FDA's Center for Devices and Radiological Health (CDRH) states that an anomaly in the firmware of the above pumps may cause loss of primary audible and visual battery alarm functionality and interruption of therapy. FDA's CDRH also states that the manufacturer initiated a recall...

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