# China NMPA Product Recall - Baby radiant warmer

Source: https://www.globalkeysolutions.net/records/china_product_recall/datex-ohmeda-inc/f2a768a1-7b97-4669-99ab-fc462d058f3a/
Source feed: China

> China NMPA product recall for Baby radiant warmer by Datex-Ohmeda, Inc. published September 05, 2024. Recall level: Level 2 Recall. On September 5, 2024, Datex-Ohmeda, Inc., a medical device manufacturer, initiated a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Datex-Ohmeda, Inc. has voluntarily recalled its baby radiant warmers.
- Company Name: Datex-Ohmeda, Inc.
- Publication Date: 2024-09-05
- Product Name: Baby radiant warmer
- Recall Level: Level 2 Recall
- Recall Reason: Some products lack electrical safety testing.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: Datex-Ohmeda, Inc.
- Summary: On September 5, 2024, Datex-Ohmeda, Inc., a medical device manufacturer, initiated a voluntary Class II recall of specific infant radiant warmers. This action was officially reported by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. The crucial issue leading to this recall stems from a deficiency in electrical safety testing for some of these products. Such testing is fundamental for medical devices, particularly those used with vulnerable populations like infants, ensuring patient safety and device reliability.
The recall operates under the regulatory framework of the National Medical Products Administration (NMPA) in China, which governs the registration and oversight of medical devices, including those with National Medical Device Registration Certificates 20153080683 and 20153080985. While Datex-Ohmeda, Inc. is the manufacturer responsible for the recall, it is important to note that the particular products implicated in this safety concern were not distributed or imported into the Chinese market. This means the direct impact of this specific recall within China is mitigated, though it highlights the manufacturer's commitment to product safety standards globally. The voluntary nature of the recall signifies the company's proactive response to address the identified safety testing lapse. Detailed information regarding the affected models and batches is provided in the "Recall Event Report Form".

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