Alerta De Seguridad O Notificaciones De Seguridad para Intra-oral dental X-ray units

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Risk of injury from falling unit after failure of the wall mount bracket.The devices were subject to a modification in 1995 and 2000 to address this risk. However, we have received a number of reports of device failure where the maintenance instructions have not been followed, and the manufacturer has not been able to confirm that all affected devices have received the modification.