# China NMPA Product Recall - Rainbow DC Series Reusable Sensors

Source: https://www.globalkeysolutions.net/records/china_product_recall/masimo-corporation/0d57cc50-5821-4ab3-a7d8-37ffcd4cdee5/
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 Chinese subsidiary Masimo (Beijing) Medical Technology Co., Ltd., in

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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 discovered that certain batches of sensors were manufactured with an incompatible configuration. This may cause the sensors to either fail to provide readings for the SpCO and SpMet parameters, or provide 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 boosted across the entire measurement range. Above 6% of SpMet measurements 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 Chinese subsidiary Masimo (Beijing) Medical Technology Co., Ltd., initiated a voluntary Level III recall of its Rainbow DC Series Reusable Sensors (Registration No. 20142215) in China. This action, reported on May 16, 2016, and publicized by the National Medical Products Administration (NMPA) on June 22, 2016, addresses critical product deficiencies.The primary issues stemmed from manufacturing inconsistencies, where certain sensor batches were produced in an incompatible configuration. This flaw could lead to either a complete failure in providing SpCO (carboxyhemoglobin) or SpMet (methemoglobin) readings, or the delivery of inaccurate data, depending on the device's firmware. Specifically, the recall noted that displayed SpCO measurements might be erroneously inflated across their range, and SpMet values exceeding 6% could exhibit an average negative bias of 1.5%.As a result of these significant performance compromises, Masimo's required action was to promptly inform affected customers to cease using the Rainbow DC Series Reusable Sensors and to facilitate the immediate return of the products. This recall impacted two units imported into China. The company's swift response, under the NMPA's regulatory oversight, aimed to mitigate potential patient safety risks associated with unreliable blood gas monitoring.

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