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

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/45247944-3a6b-4984-833a-fa8e67ce1b33/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Shimadzu Enterprise Management (China) Co., Ltd. published December 06, 2021. Recall level: Level 3 Recall. On December 6, 2021, Shimadzu Enterprise Management (China) Co., Ltd. voluntarily initiated a Class 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shimadzu Enterprise Management (China) Co., Ltd. is voluntarily recalling medical angiography X-ray machines.
- Company Name: Shimadzu Enterprise Management (China) Co., Ltd.
- Publication Date: 2021-12-06
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 3 Recall
- Recall Reason: If the maximum dose rate is not confirmed strictly according to the manufacturer's commissioning procedures during equipment installation and commissioning, the irradiation dose rate may exceed the manufacturer's specified limit when performing non-standard exposure procedures.
- Discovering Company: Shimadzu Enterprise Management (China) Co., Ltd.
- Manufacturing Company: Shimadzu Enterprise Management (China) Co., Ltd.
- Summary: On December 6, 2021, Shimadzu Enterprise Management (China) Co., Ltd. voluntarily initiated a Class III recall for specific models of its medical angiography X-ray machines. This action was taken due to a potential safety concern identified with the equipment. There is a very small probability that if the maximum dose rate is not strictly confirmed according to the manufacturer's detailed commissioning procedures during the initial installation and setup, the irradiation dose rate could exceed the company's specified limits when performing non-standard exposure procedures. This issue could pose a risk to patient safety by potentially exposing them to higher-than-intended radiation levels. The recall, reported via the Shanghai Municipal Drug Administration Website, falls under the regulatory oversight of the National Medical Products Administration (NMPA), referenced by Index No. JGXX-2021-10672. The affected devices carry Registration Certificate No.: 国食药监械（进）字2011第3303994号（更）, with comprehensive details on models, specifications, and batches provided in an attached "Medical Device Recall Event Report Form." This voluntary recall underscores Shimadzu Enterprise Management's commitment to product safety and compliance with medical device regulations, aiming to rectify the identified issue and ensure the consistent and safe operation of their X-ray machines in clinical settings.

Company: https://www.globalkeysolutions.net/companies/shimadzu-enterprise-management-china-co-ltd/45f5c532-93c8-4552-9b59-604e7c9cba23/