# China NMPA Product Recall - Nellcor™ OxiMax® N-65 Handheld Pulse Oximeter, Nellcor™ OxiMax® N-560 Pulse Oximeter

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/ae4160d4-3f49-4a84-8bb5-02e1f9f4e683/
Source feed: China

> China NMPA product recall for Nellcor™ OxiMax® N-65 Handheld Pulse Oximeter, Nellcor™ OxiMax® N-560 Pulse Oximeter by Covidien llc published May 25, 2015. Recall level: Level 3 Recall. Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a subsidiary of the Medtronic G

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of its pulse oximeter.
- Company Name: Covidien llc
- Publication Date: 2015-05-25
- Product Name: Nellcor™ OxiMax® N-65 Handheld Pulse Oximeter, Nellcor™ OxiMax® N-560 Pulse Oximeter
- Recall Level: Level 3 Recall
- Recall Reason: The product failed to display the numbers completely on the screen, which may cause users to misunderstand the final numerical display result.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a subsidiary of the Medtronic Group, initiated a voluntary recall on May 25, 2015, for specific pulse oximeter models. The affected products, which include the Nellcor™ OxiMax® N-65 Handheld Pulse Oximeter and Nellcor™ OxiMax® N-560 Pulse Oximeter, presented a critical malfunction: their screens failed to display numbers completely. This defect could lead healthcare professionals to misinterpret vital patient data, specifically blood oxygen saturation and pulse rate, potentially compromising patient safety. The recall was conducted under the oversight of the National Medical Products Administration (NMPA) and applied globally, affecting 2090 units in China. As required actions, Covidien issued a Medical Device Safety Warning and notified all relevant customers via a formal letter. Customers were instructed to perform a Post-Activation Self-Test (POST) before each patient use to verify device functionality and were also required to complete and return a confirmation form to Covidien, ensuring acknowledgment of the safety measures.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/