China NMPA Product Recall - Linear accelerator

The National Medical Products Administration (NMPA) issued a recall notice on September 9, 2011, regarding linear accelerators manufactured by Varian Medical Systems, Inc. The recall stems from an identified issue where drive base bolts in certain batches of these devices did not meet mechanical specifications. This deficiency could potentially lead to center misalignment in the linear accelerators, which are critical for radiotherapy. While Varian Medical Systems, Inc. indicated this specific recall does not affect the Chinese market, the NMPA, operating under its medical device regulatory framework (previously CFDA), requested local food and drug administrations to strengthen supervision over such products.

Globally, Varian Medical Systems, Inc. is implementing several corrective actions. The company will notify affected users via product notification letters and field service notices. Subsequently, Varian will contact relevant medical centers to replace the non-conforming base bolts and verify the equipment's center alignment. If required, service engineers will be dispatched to adjust the linear accelerators to ensure their precise and safe operation.