# China NMPA Product Recall - Medical angiography X-ray machine; X-ray angiography system

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/025c8605-5a2b-415d-ba20-2e9764fb0e18/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine; X-ray angiography system by Siemens Healthineers Co., Ltd. published June 24, 2019. Recall level: Level 2 Recall. Siemens Healthineers Ltd. initiated a voluntary Class II recall for several models of its medical an

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers is voluntarily recalling its medical angiography X-ray machines, X-ray angiography systems, and related products.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2019-06-24
- Product Name: Medical angiography X-ray machine; X-ray angiography system
- Recall Level: Level 2 Recall
- Recall Reason: The product in question has a very small chance of developing a loose or broken screw in the pivot bearing that connects the DCS (Display Mount Extension) to the ceiling bracket. This issue is infrequent and depends primarily on the frequency of use of the mount.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: Siemens Healthineers Ltd. initiated a voluntary Class II recall for several models of its medical angiography X-ray machines, as announced by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on June 24, 2019. This proactive action addresses a potential manufacturing issue involving the screws connecting the pivot bearing to the ceiling bracket on the Display Mount Extension (DCS). There is a very small possibility that these screws could loosen or break, with the frequency of this occurrence being dependent on how often the hanger is used. This recall pertains to specific medical angiography X-ray systems, identified by various National Medical Device Registration Certificates. Siemens Healthineers Ltd. is voluntarily recalling these products to ensure patient safety and device integrity. Detailed information concerning the affected models, specifications, and batch numbers is available in an accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/