0 century 80s, due to the hospital funds and approval of the limitations of the introduction of new CT equipment, a large number of second-hand CT into China's hospitals at all levels, the repair and maintenance of these devices, lack of information, no source of spare parts, relying on repair parts and dismantling of the old equipment parts to complete. As the main diagnostic body of Class III medical devices - CT equipment is still second-hand, for the ancillary parts of Class II medical devices - bulb tube and a variety of repair parts, its source and quality is directly ignored.
This led to a high failure rate and low diagnostic accuracy of CT equipment in many hospitals at that time. In order to change this state of affairs, the Ministry of Health and the State Planning Commission jointly issued the Notice on Issues Related to Strengthening the Management of Large-scale Medical Used Equipment in 1996, which explicitly banned the import and use of any form of used medical equipment.
The balloon used as a repair, although it is a Class II medical device, did not attract the attention of regulators, so the repair or removal of old balloon has been widely used by maintenance companies, these needs have led to a number of repair and removal of old balloon as a specialized business companies, these companies focus on the domestic balloon research and development has also played a positive role in the development.