China NMPA Product Recall - Brachytherapy planning system

NUCLETRON B.V. and its agent, Elekta (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Class III recall of their brachytherapy planning system (Oncentra Brachy), as detailed in the National Medical Products Administration (NMPA) document JGXX-2017-10908, published on 2017-09-27. The recall, stemming from a report dated 2017-08-23, addresses a critical flaw in the system’s applicator modeling function.

The primary issue involved inaccurate step length calculations for ring or crescent-shaped applicators. Specifically, when creating plans for microSelectron aftermarket units, an incorrect default step size (e.g., 5.0mm or 10.0mm instead of the required 2.5mm) could lead to a discrepancy between the displayed and actual treatment step sizes. If undetected during commissioning or plan review, this error could cause a shift in the treatment position, resulting in incorrect radiation delivery.

To mitigate the risk, NUCLETRON B.V. issued a security notice, strongly advising microSelectron aftermarket users to ensure a default step size of 2.5mm in their TDStore prior to any software upgrade. The company also committed to resolving this flaw in the next software version, with subsequent upgrades provided to all affected customers. The document noted that products sold in China for ring applicators with Oncentra Brachy were not impacted by this specific recall.