# China NMPA Product Recall - Single-photon emission and X-ray computed tomography system

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-ge-healthcare-co-ltd/307571ef-9130-4e6d-88ed-28fe60630058/
Source feed: China

> China NMPA product recall for Single-photon emission and X-ray computed tomography system by Beijing GE Healthcare Co., Ltd. published March 06, 2023. Recall level: Level 1 Recall. Beijing GE Healthcare Medical Equipment Co., Ltd. initiated a recall for specific models and batches

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing GE Healthcare Co., Ltd. is recalling and modifying its single-photon emission and X-ray computed tomography (SPECT) systems.
- Company Name: Beijing GE Healthcare Co., Ltd.
- Publication Date: 2023-03-06
- Product Name: Single-photon emission and X-ray computed tomography system
- Recall Level: Level 1 Recall
- Recall Reason: The problem of the detector falling
- Discovering Company: Beijing GE Healthcare Co., Ltd.
- Manufacturing Company: Beijing GE Healthcare Co., Ltd.
- Summary: Beijing GE Healthcare Medical Equipment Co., Ltd. initiated a recall for specific models and batches of its Single-Photon Emission Tomography (SPEE) and X-ray Computed Tomography systems. The action was prompted by a potential detector drop issue identified in these medical devices. Under the oversight of the National Medical Products Administration (NMPA), the company reported this significant safety concern. Initially, a voluntary recall was issued. However, on March 20th, Beijing GE Healthcare Medical Equipment Co., Ltd. escalated the severity of this action by changing the recall level from Level II to Level I. This change signifies a higher risk assessment associated with the defect. Concurrently, the company broadened the scope of the recall to include an expanded range of affected products, specifying additional models, specifications, and batches that are now subject to the recall. This comprehensive amendment was documented in a "Medical Device Recall Event Report Form (Amendment Form)," ensuring detailed communication of the updated recall parameters to the NMPA and the public. This proactive measure aims to mitigate potential patient safety risks associated with the identified detector drop issue.

Company: https://www.globalkeysolutions.net/companies/beijing-ge-healthcare-co-ltd/81b8f648-b549-4e0a-ae4e-0bdf363fe37e/