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 Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning FUJIFILM Corporation Digital X-ray system FDR nano [HKMD No.: 200449].
According to MHRA, the manufacturer has recently been alerted to examinations carried out in pediatric, neonatal and maternity departments with default exposure values that are intended for adult chest imaging and could lead to a risk of overexposure.
For further information, please visit https://mhra-gov.filecamp.com/s/d/d6WpPf7ZpD0vAeKN
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Feb 2024