China NMPA Product Recall - Medical angiography X-ray system

Philips (China) Investment Co., Ltd., in collaboration with manufacturer Philips Medical Systems Nederland B. V., initiated a voluntary Class III recall for its Medical Angiography X-ray Systems. This action, reported to the National Medical Products Administration (NMPA) on December 5, 2016, and publicly announced on December 29, 2016, addresses a significant manufacturing error.

The core issue stems from bolts not being tightened to the specified torque during production, potentially causing them to detach from the C-arm shaft. This defect could lead to uncontrolled rotation and malfunction of the C-arm, which is crucial for clinical vascular and cardiovascular interventional procedures. The recall affects a specific unit, an Allura Xper FD20 model (Serial Number: 2786), imported and sold in China, though the underlying issue has global relevance. Fortunately, no patient injuries related to this manufacturing defect have been reported thus far.

In response to NMPA's regulatory framework, Philips is undertaking comprehensive corrective actions. The company plans to rectify the problem through field change orders, providing the necessary repairs and adjustments to all affected users at no cost. Philips has committed to contacting all customers directly to confirm the successful implementation of these corrective measures, ensuring product safety and operational integrity.