# China NMPA Product Recall - Baby warming station

Source: https://www.globalkeysolutions.net/records/china_product_recall/ohmeda-medical/5849d5e6-3938-40ad-bf23-fa37df16285a
Source feed: China

> China NMPA product recall for Baby warming station by Ohmeda Medical published September 28, 2016. Recall level: Level II. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a Level II voluntary recall

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. has initiated a voluntary recall of baby warmers.
- Company Name: Ohmeda Medical
- Publication Date: 2016-09-28
- Product Name: Baby warming station
- Recall Level: Level II
- Recall Reason: GE recently learned that there is a potential risk of loose screws in the heating element of the IWS model radiant warmer. If the heating element is not properly maintained, the heated screws may fall onto the mattress and come into contact with the patient, posing a clinical risk.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: Ohmeda Medical
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a Level II voluntary recall of its Baby Warmers due to a significant safety concern. The recall, internally reported on August 10, 2016, and publicly announced by the National Medical Products Administration (NMPA) on September 28, 2016, addresses the potential for loose screws within the radiant heating element of the devices. If not properly maintained, these heated screws could detach, fall onto the mattress, and come into direct contact with infant and pediatric patients, posing a serious clinical risk. The affected products include various models (e.g., 2001, 3000, 4000 series) manufactured by Ohmeda Medical, with 254 units imported and sold in China, and a broader distribution across countries including the USA, Australia, and Canada. As a corrective action, GE Healthcare is distributing a customer letter to all users. This communication includes an essential supplementary appendix to the product's service manual, providing specific, detailed guidance to maintenance personnel to ensure proper handling and prevent the identified issue, thereby mitigating the risk and ensuring the safe operation of the affected baby warmers.

Company: https://www.globalkeysolutions.net/companies/ohmeda-medical/1b069dd9-c5ca-4d87-890f-3b3d07bedf7f