China NMPA Product Recall - Alice 6 LDxN, Alice 6 LDxS polysomnography recorders, BiPAP A30 ventilator, and pulse oximeter leads for the Trilogy 100 ventilator.

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall on April 14, 2015, for specific medical devices due to a critical accessory defect. The recall affects Alice 6 LDxN and Alice 6 LDxS Polysomnography Recorders, BiPAP A30 Ventilators, and Trilogy 100 Ventilator accessory pulse oximeter leads. The main issue, reported by the supplier Masimo, involves internal wiring problems within a small number of pulse oximeter leads. This defect causes erroneous oxygen saturation readings, specifically displaying a high value when the actual saturation is low, and conversely, a low value when saturation is high, which could potentially impact patient care. Operating under the regulatory framework of the National Medical Products Administration (NMPA), Philips is undertaking required actions. The company is issuing advisory notices to affected distributors and end customers globally. Customers will be guided to return the faulty pulse oximeter leads for replacement or refund. A simple diagnostic method has been provided to identify defective leads, ensuring prompt identification and resolution of the issue.