# China NMPA Product Recall - Ultrasound diagnostic instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-austria-gmbh-co-og/00dc5231-15d7-42ca-bed2-83b6a621b594/
Source feed: China

> China NMPA product recall for Ultrasound diagnostic instrument by GE Healthcare Austria GmbH & Co OG published August 09, 2019. Recall level: Level 2 Recall. GE Healthcare Austria GmbH & Co OG initiated a voluntary Class II recall of its ultrasound diagnosti

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Austria GmbH & Co OG voluntarily recalls ultrasound diagnostic equipment
- Company Name: GE Healthcare Austria GmbH & Co OG
- Publication Date: 2019-08-09
- Product Name: Ultrasound diagnostic instrument
- Recall Level: Level 2 Recall
- Recall Reason: The probe sensor was not aligned and there was a certain deviation.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Austria GmbH & Co OG
- Summary: GE Healthcare Austria GmbH & Co OG initiated a voluntary Class II recall of its ultrasound diagnostic instruments, as reported on August 9, 2019, by the National Medical Products Administration (NMPA). The primary issue identified is a potential misalignment of the probe sensor within these devices. This defect could compromise the accuracy and reliability of diagnostic imaging, potentially posing risks to patient care. The recall specifically targets certain models and batches of ultrasound diagnostic instruments, identified by registration certificate numbers such as 国械注进20152061495 and 国食药监械（进）字2014第2234370号. While the document does not specify inspection dates, the recall itself is a regulatory action managed under the NMPA's framework. As a Class II recall, this indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. GE Healthcare Austria GmbH & Co OG is required to provide comprehensive details, including specific models, specifications, and batch numbers, in a "Recall Event Report Form" to facilitate the retrieval of all affected products from the market and ensure public safety.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-austria-gmbh-co-og/a9ad6dfe-64df-4ec1-9112-77243d8ee4a1/