GE—Vivid E9 4D Cardiovascular Ultrasound Systems: May Lock Up
October 30, 2013 | Risk Management News
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In an October 11, 2013, Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, GE states that the keyboard response time on the systems below may increase, potentially resulting in the eventual lock-up of the system. The problem relates only to the above systems, software versions, and serial numbers when used together with the 4D TEE (6VT-D) probe for certain types of procedures. During procedures where the 4D TEE (6VT-D) probe is used over an extended period of time, the Vivid E9 scanner may gradually become unresponsive, requiring the scanner to be rebooted and potentially resulting in risk to patients when tranesophageal echocardiology (TEE) is performed. The manufacturer has not confirmed the...