Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.
Reason for recall: Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor. Distribution: US Nationwide - Worldwide Quantity: 4 distributed in U.S. Lot/code info: Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
04056869009117
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.