Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning FUJIFILM Healthcare Americas Corporation Mobile X-ray system [FDR D-EVO2 (DR-ID) 12XXSE)] [HKMD No.: 200507].
According to the FDA, when the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95320
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Sep 2024