Edwards—EV1000A Clinical Platforms: Noncompliant Installation Configuration May Result in Shock and Fire Hazard
June 8, 2016 | Strategic Insights for Health System
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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 an April 29, 2016, Product Notification letter submitted by ECRI Institute member hospitals, Edwards states that noncompliant installation configuration of the above systems may cause fluid ingress to the power supply, presenting a shock and fire hazard. The manufacturer has not confirmed the...