Regulator issues warning about safety of a suspended x-ray unit

The UK safety regulator for medical devices has issued a medical device alert for the Satella-X ceiling suspended skull x-ray unit.

The unit is manufactured by Nordisk Roentgen Teknik (NRT) and was distributed from 1980 to 2006.

The warning has been issued as there is a possibility of a risk of injury to patients and users because of the tube and detector arm dropping to the floor. This is because there is a chance that the locking nuts securing the ball spindle in the vertical arm can become loose allowing the spindle to drop from its top bearing.

NRT has initiated a field safety corrective action that will prevent this happening.

Medical staff working in radiology units in hospitals throughout the UK have been informed about the threat of injury from the x-ray unit and are being encouraged to report any incidents involving the equipment via the yellow card scheme.

NRT originally issued a field safety notice about the unit in January 2015 but the MHRA is following up that notice with a medical device alert as the regulator is concerned that it did not reach everyone using the equipment.