China NMPA Product Recall - Medical magnetic resonance imaging equipment

Deerfield Imaging, Inc. initiated a voluntary Class III recall of its medical magnetic resonance imaging equipment following a safety concern. The National Medical Products Administration (NMPA) published this recall on November 29, 2018, based on a report dated November 26, 2018. The primary issue identified is the potential aging of the sealing O-ring within the operating table roller check valve after extended use. This degradation could result in unexpected angular displacement of the operating table, presenting a potential risk of injury to patients during MRI examinations.The recall affects 70 units globally, including specific models and batches, with 8 units sold in China. The scope of impact extends to regions such as the United States, Canada, and China. Under the NMPA's regulatory oversight, Deerfield Imaging, Inc., through its agent, is mandated to implement several corrective actions. These actions include promptly notifying all potentially affected customers and arranging for on-site correction plans. Crucially, the company must replace the faulty roller check valve in all identified operating tables and conduct post-replacement drift testing to confirm normal function and ensure the equipment's safe and reliable operation. This comprehensive response aims to effectively address the identified safety hazard.