# China NMPA Product Recall - Mobile C-arm X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-oec-medical-systems-inc/4e0847fd-8a23-4894-9cba-960426e8d8ef/
Source feed: China

> China NMPA product recall for Mobile C-arm X-ray machine by GE OEC Medical Systems, Inc. published June 01, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on June 1, 2023, a voluntary Class II 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE OEC Medical Systems, Inc. is voluntarily recalling its mobile C-arm X-ray machines.
- Company Name: GE OEC Medical Systems, Inc.
- Publication Date: 2023-06-01
- Product Name: Mobile C-arm X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: The 9” image intensifier may detach due to improper transportation and significant impact.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE OEC Medical Systems, Inc.
- Summary: The National Medical Products Administration (NMPA) announced on June 1, 2023, a voluntary Class II recall initiated by GE OEC Medical Systems, Inc. The recall involves specific models of Mobile C-arm X-ray Machines, following reports from GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. The main issue identified is the potential detachment of the 9-inch image intensifier. This critical safety concern is attributed to improper orientation of the device during transportation, which, when combined with significant impact, can lead to the component becoming dislodged. The affected machines are identified by NMPA Import Permit Numbers 20132301853, 20172300822, and 20193060162. A Class II recall signifies that the product's use or exposure could lead to temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. The company is taking this action to mitigate potential risks to patients and users, with further comprehensive details on affected product batches available in the 'Medical Device Recall Event Report Form'.

Company: https://www.globalkeysolutions.net/companies/ge-oec-medical-systems-inc/6ef83ead-6c29-4473-b97d-60bc22e65183/