GE—OEC Fluorostar 7900 Fluoroscopic Systems: Touch Panel May Become Locked during Cine Save

January 11, 2012 | Risk Management News

Preview

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 December 13, 2011, Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), GE states that the touch panel of the systems below may become locked if the “Pause/Forward/Backward” buttons are pressed during the cine save process. If this problem occurs, the image may freeze, the application may self-terminate, and the system may emit audible and visual alarms. If the application terminates during the cine save procedure, the cine strip may not be completely saved, and images not saved before the application terminates may be lost. The manufacturer has not confirmed the...

Access Full Content

Contact us today at 610.825.6000.