The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera manufactured by GE Healthcare, LLC. All Infinia systems and all configurations are affected.
According to the safety alert, accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide, which may impact patient and operators.
For details, please visit the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=64398&w=04172013&lang=eng
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 18 April 2013