# China NMPA Product Recall - Neonatal Incubator

Source: https://www.globalkeysolutions.net/records/china_product_recall/datex-ohmeda-inc/3899a307-26dd-4442-b822-755bab136010/
Source feed: China

> China NMPA product recall for Neonatal Incubator by Datex-Ohmeda, Inc. published December 17, 2019. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) has announced a voluntary Class I recall initiat

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Datex-Ohmeda, Inc. is voluntarily recalling medical devices including the Neonatal Incubator.
- Company Name: Datex-Ohmeda, Inc.
- Publication Date: 2019-12-17
- Product Name: Neonatal Incubator
- Recall Level: Level 1 Recall
- Recall Reason: The product in question may have issues with the bed board and box opening not being locked.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: Datex-Ohmeda, Inc.
- Summary: The National Medical Products Administration (NMPA) has announced a voluntary Class I recall initiated by Datex-Ohmeda, Inc., impacting their Neonatal Incubators (Registration Certificate No.: 20183540070, among others). This recall was reported by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. The critical issue identified is a potential defect where the bed board and incubator opening may not securely lock. This poses a significant safety risk, leading to the Class I classification, which indicates a reasonable probability of serious adverse health consequences or death. Datex-Ohmeda, Inc. is undertaking a voluntary recall of these affected medical devices to mitigate potential hazards. Comprehensive details regarding the specific product names, registration certificate numbers, models, specifications, and batch numbers of the impacted Neonatal Incubators are provided in accompanying attachments by the NMPA, ensuring transparency and facilitating necessary actions to uphold patient safety under the NMPA’s stringent regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/datex-ohmeda-inc/3f7d50b4-53f8-4a07-a7a6-7a3c0147c9e2/