Medical device manufacturer, Medtronic Ltd., has issued a field safety notice concerning O-arm Imaging Systems. The affected serial numbers are from 101 to 564.
The manufacturer has identified a potential failure in the braking system that controls the O-arm gantry's vertical movement. This potential failure exists when the O-arm gantry is in a raised position, and could result in an uncontrolled descent when the Up/Down Button is released. The gantry would stop when coming to rest on the hard stop on the horizontal frame of the device or reaching the end of travel (which could include contact with the patient and/or protruding instrumentation within the bore of the system). According to the manufacturer, this potential failure has no impact on the amount of radiation emission delivered by the system, and there have been no reports of this or similar events occurring at any customer site.
If the transistor component fails, the gantry could experience an uncontrolled descent until coming to rest on the hard stop on the horizontal frame of the device or reaching the end of travel. The falling gantry could contact the patient, or protruding instrumentation within the bore of the system. This has the potential to result in serious injury or death to the patient, or injury to users, or both.
The manufacturer will implement an improved circuit for the braking system that controls the O-arm gantry's vertical movement. This improved circuit will be implemented by replacing the motion control box on all affected O-arm Imaging systems. Furthermore, the manufacturer advises that the risk of the adverse health consequences described can be reduced by setting the OR table/patient height from the floor as low as possible.
According to the local supplier, Medtronic International Limited, the affected devices were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 January 2013