China NMPA Product Recall - HD120 MLC Multi-leaf Collimator

The National Medical Products Administration (NMPA) issued a notice on December 13, 2011, regarding a voluntary recall initiated by Varian Medical Systems, Inc., based on a report from November 23, 2011. The recall concerned the company's HD120 MLC Multileaf Collimator. The primary issue identified was that the device, when used for beam shaping in patient radiotherapy, could deliver a radiation dose outside the planned treatment field, resulting in an over-delivery of the expected dose. While the recall was global, Varian Medical Systems stated that no affected products were sold within the Chinese market.

In response, Varian committed to sending an "Emergency Medical Device Correction Notice" to all potentially impacted customers worldwide. The company also declared its intention to explore future improvements to reduce unintended out-of-target radiation doses. The NMPA directed its provincial and municipal food and drug administrations to enhance their supervision and management of similar medical devices, emphasizing the need for continuous oversight in the medical device sector.