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

Source: https://www.globalkeysolutions.net/records/china_product_recall/masimo-corporation/ce68b339-4cc0-4d45-befd-b1b6578bc987/
Source feed: China

> China NMPA product recall for Alice 6 LDxN, Alice 6 LDxS polysomnography recorders, BiPAP A30 ventilator, and pulse oximeter leads for the Trilogy 100 ventilator. by MASIMO CORPORATION published April 14, 2015. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall on April 14, 2015, for sp

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling the pulse oximeter leads for the Alice 6 LDxN, Alice 6 LDxS polysomnography recorders, BiPAP A30 ventilator, and Trilogy 100 ventilator.
- Company Name: MASIMO CORPORATION
- Publication Date: 2015-04-14
- Product Name: Alice 6 LDxN, Alice 6 LDxS polysomnography recorders, BiPAP A30 ventilator, and pulse oximeter leads for the Trilogy 100 ventilator.
- Recall Level: Level 2 Recall
- Recall Reason: Philips received notification from Masimo, the supplier of the pulse oximeter leads for its products, that Masimo had discovered internal wire mixing in a small number of pulse oximeter leads. This wire mixing affects instrument performance as follows: when the measured value is low blood oxygen saturation, the monitor displays a high blood oxygen saturation value. Conversely, using the same pulse oximeter leads, when the measured value is high blood oxygen saturation, the monitor displays a low blood oxygen saturation value.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: MASIMO CORPORATION
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/masimo-corporation/3c8a1f36-accd-4fd4-98d9-b80fa6ddd82d/