Clinicians may continue to use their devices, but should be aware of a potential safety issue involving unresponsive buttons on the device display. Due to a manufacturing issue the buttons on the left, right, and bottom keypads may not always detect a user’s button presses. This may result in the inability to access certain menu functions which could possibly lead to delay in treatment.
GE Healthcare has begun notifying customers with affected units through an Urgent Medical Device Correction letter, which alerts users of the concern and provides instructions to mitigate the issue. The instructions explain that to mitigate this issue: (1) The user may notice that a button press may not actuate the desired function. Usually by pressing the key again, the device will respond as expected. (2) If a button has no response, the menu function may be accessible through the use of the control wheel. The instructions direct that if none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative.