# China NMPA Product Recall - Ultrasound diagnostic instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/hitachi-aloca-medical-co-ltd/e79a5d65-3acd-48fd-bc58-50bd8bea035d/
Source feed: China

> China NMPA product recall for Ultrasound diagnostic instrument by Hitachi Aloca Medical Co., Ltd. published May 07, 2014. Recall level: . Hitachi Aloka Medical Co., Ltd. initiated a voluntary recall for its Ultrasound Diagnostic Instrumen

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hitachi Aloka Medical Co., Ltd. of Japan has recalled its ultrasound diagnostic equipment.
- Company Name: Hitachi Aloca Medical Co., Ltd.
- Publication Date: 2014-05-07
- Product Name: Ultrasound diagnostic instrument
- Recall Reason: Hitachi Aloka Medical Co., Ltd. discovered that there may be a defect in the electrical components on the CPU motherboard of this product. If the CPU fails due to the faulty electrical components, it may emit smoke or a foul odor.
- Discovering Company: Hitachi Medical (Guangzhou) Co., Ltd.
- Manufacturing Company: Hitachi Aloca Medical Co., Ltd.
- Summary: Hitachi Aloka Medical Co., Ltd. initiated a voluntary recall for its Ultrasound Diagnostic Instruments, F37 Model, as reported to China's National Medical Products Administration (NMPA) by Hitachi Medical (Guangzhou) Co., Ltd. on April 29, 2014. The recall was prompted by a discovered defect: an electrical component on the CPU motherboard that could malfunction, potentially causing smoke or a foul odor. The manufacturer confirmed this defect does not present a fire hazard or risk of serious injury, and no adverse events have been reported. Operating under the NMPA's regulatory oversight for imported medical devices, Hitachi Aloka Medical Co., Ltd. committed to replacing the defective CPU motherboards in affected products. However, this recall is primarily an overseas action, impacting units sold in Japan (identified by specific serial numbers). Crucially, none of the affected ultrasound devices were imported or sold within China. Therefore, while the NMPA was informed, Hitachi Medical (Guangzhou) Co., Ltd. is not undertaking further recall measures in China. Chinese provincial food and drug administrations were advised to strengthen their supervision. The initial recall report was dated April 25, 2014, with the NMPA publishing the announcement on May 7, 2014.

Company: https://www.globalkeysolutions.net/companies/hitachi-aloca-medical-co-ltd/2e3bc9c5-5965-4079-b025-54cb56812bc6/