Safety Alert Or Field Safety Notices for UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems

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.

The MHRA has received a report of the X-ray tube head falling onto the table after the support cable and the backup ‘safety device’ failed simultaneously. The tube head weighs 40 kg and there is a risk of death or serious patient injury if this failure occurs during examination.The X-ray tube head is supported by a metal rope that winds over a pulley system behind the tube support covers. There is a safety device fitted, which should catch the rope if it breaks.Wear on the cable may go undetected as the current service instructions for this device do not require that the whole length of the cable is inspected nor do they require that the ‘safety device’ is inspected.The manufacturer has updated the service instructions and issued a Field Safety Notice, available to download from:X-ray, ancillary equipment and accessories - Mecall Srl - UNISTAT L floor stand.