# China NMPA Product Recall - Rainbow DC Series Reusable Sensors

Source: https://www.globalkeysolutions.net/records/china_product_recall/masimo-corporation/a74f7ef4-9886-4d2d-bd5d-fd2f7701c85b/
Source feed: China

> China NMPA product recall for Rainbow DC Series Reusable Sensors by MASIMO CORPORATION published June 22, 2016. Recall level: Level 3 Recall. Masimo Corporation, through its Masimo (Beijing) Medical Technology Co., Ltd. subsidiary, initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Masimo Corporation is voluntarily recalling its Rainbow DC Series Reusable Sensors.
- Company Name: MASIMO CORPORATION
- Publication Date: 2016-06-22
- Product Name: Rainbow DC Series Reusable Sensors
- Recall Level: Level 3 Recall
- Recall Reason: (1) Masimo has identified certain batches of sensors manufactured with an incompatible configuration. This may result in the sensor either failing to provide SpCO readings or providing inaccurate readings. Specific behavior will depend on the firmware version of the technology board in the device. (2) SpCO measurements (when displayed) may be incorrectly inflated across the entire measurement range. Values above 6% may be subject to a 1.5% negative bias (on average).
- Discovering Company: Mycinno (Beijing) Medical Technology Co., Ltd.
- Manufacturing Company: MASIMO CORPORATION
- Summary: Masimo Corporation, through its Masimo (Beijing) Medical Technology Co., Ltd. subsidiary, initiated a voluntary Class III recall of its Rainbow DC Series Reusable Sensors. This action was publicly announced by the National Medical Products Administration (NMPA) on June 22, 2016. The recall stems from manufacturing irregularities where specific batches of sensors were produced with incompatible configurations. These manufacturing flaws could result in significant performance issues, including the complete failure to provide SpCO (carboxyhemoglobin) readings or the delivery of inaccurate and potentially inflated measurements across the full range. The exact behavior of the affected sensors is dependent on the firmware version of the device’s technical board. Furthermore, Masimo identified that other elements, such as white matter content exceeding six percent, could contribute to an average negative bias of 1.5 percent. The company's proactive recall under the NMPA framework highlights its dedication to product safety and regulatory compliance, with detailed information about affected products available in the official "Medical Device Recall Event Report Form."

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