# China NMPA Product Recall - Flow sensor

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/4103d569-cc4b-4225-a1f7-05be3eb17748/
Source feed: China

> China NMPA product recall for Flow sensor by GE Healthcare (China) Co., Ltd. published September 24, 2021. Recall level: Level 2 Recall. GE Healthcare (China) Co., Ltd. initiated a voluntary Class II recall for certain flow sensors manuf

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare (China) Co., Ltd. initiates voluntary recall of flow sensors
- Company Name: GE Healthcare (China) Co., Ltd.
- Publication Date: 2021-09-24
- Product Name: Flow sensor
- Recall Level: Level 2 Recall
- Recall Reason: A small number of flow sensors manufactured before June 2021 have experienced tubing damage, which could lead to leaks and cause the anesthesia system to display incorrect gas readings, potentially resulting in over-ventilation of the patient.
- Discovering Company: GE Healthcare (China) Co., Ltd.
- Manufacturing Company: GE Healthcare (China) Co., Ltd.
- Summary: GE Healthcare (China) Co., Ltd. initiated a voluntary Class II recall for certain flow sensors manufactured prior to June 2021. The recall, reported on September 24, 2021, addresses a critical product deficiency where a small number of these flow sensors were found to have damaged tubing. This defect can lead to leakage and, consequently, inaccurate gas readings within anesthesia systems. The primary concern arising from this issue is the potential for patient over-ventilation, posing a significant risk to patient safety during medical procedures.This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration. The company's proactive measure to conduct a voluntary recall underscores its commitment to product quality and patient safety. Specific details regarding the affected products are available in the accompanying "Medical Device Recall Event Report Form," enabling healthcare providers to identify and address the recalled units effectively. The voluntary nature and Class II designation of the recall indicate a serious potential health risk that requires prompt corrective action to mitigate adverse patient outcomes.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-china-co-ltd/54e52bc9-beef-4ac4-a7d7-a5f2c9dbe214/