# China NMPA Product Recall - Rainbow DC Series Reusable Sensors

Source: https://www.globalkeysolutions.net/records/china_product_recall/masimo-corporation/fe379fb3-ae3c-41d3-a947-f601ba3a9f26/
Source feed: China

> China NMPA product recall for Rainbow DC Series Reusable Sensors by MASIMO CORPORATION published July 07, 2016. Recall level: Level 3 Recall. On May 16, 2016, Masimo Corporation initiated a voluntary Level III recall of certain batches of its

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Masimo Corporation is voluntarily recalling its Rainbow DC Series Reusable Sensors.
- Company Name: MASIMO CORPORATION
- Publication Date: 2016-07-07
- 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 sensor 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: On May 16, 2016, Masimo Corporation initiated a voluntary Level III recall of certain batches of its Rainbow DC Series Reusable Sensors, as reported to the National Medical Products Administration (NMPA). The recall, handled in China by Masimo (Beijing) Medical Technology Co., Ltd., addresses significant manufacturing issues. It was discovered that some sensors were produced with an incompatible configuration, leading to potential failures in providing accurate readings for parameters such as SpCO (carboxyhemoglobin saturation) and SpMet (methemoglobin saturation), or delivering entirely inaccurate measurements. Specifically, SpCO measurements might be incorrectly elevated, and SpMet readings could show a negative bias, potentially exceeding 6%. In response, Masimo Corporation mandated immediate notification to customers to cease using the affected products and initiated the comprehensive recall of the identified sensor batches to mitigate any patient safety or diagnostic accuracy concerns.

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