# China NMPA Product Recall - X-ray diagnostic system, digital X-ray imaging and fluoroscopy system, digital urological X-ray system

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-gmbh/18f5b0fa-470f-45ca-bc7f-579b0703e9fd/
Source feed: China

> China NMPA product recall for X-ray diagnostic system, digital X-ray imaging and fluoroscopy system, digital urological X-ray system by Siemens Healthcare GmbH published January 16, 2023. Recall level: Level 3 Recall. Siemens Healthineers, comprising Siemens AG and Siemens Healthcare GmbH, has initiated a voluntary C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens AG and Siemens Healthcare GmbH are voluntarily recalling X-ray diagnostic systems, digital X-ray imaging fluoroscopy systems, and digital urological X-ray systems.
- Company Name: Siemens Healthcare GmbH
- Publication Date: 2023-01-16
- Product Name: X-ray diagnostic system, digital X-ray imaging and fluoroscopy system, digital urological X-ray system
- Recall Level: Level 3 Recall
- Recall Reason: Because this involves specific product models and batches, under certain circumstances, spatial configuration data may be lost and revert to default values, potentially causing collisions between the system and the surrounding room.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthcare GmbH
- Summary: Siemens Healthineers, comprising Siemens AG and Siemens Healthcare GmbH, has initiated a voluntary Class III recall for specific X-ray diagnostic systems, digital X-ray imaging fluoroscopy systems, and digital urological X-ray systems. Announced by the National Medical Products Administration (NMPA) on January 16, 2023, this action addresses a significant product deficiency.The core issue involves the potential loss of spatial configuration data in particular models and batches. This defect could lead to the systems reverting to default spatial settings, creating a risk of collision with surrounding room environments during operation. While the document does not specify inspection dates, it details the company's prompt response to mitigate this safety concern.Operating under the NMPA's regulatory oversight, Siemens Healthineers is executing this voluntary recall to uphold patient and operator safety. The required action involves identifying and recalling the affected devices. Further comprehensive information regarding the precise product models, specifications, and batches impacted is available in the accompanying "Medical Device Recall Event Report Form." This recall highlights the company's commitment to product safety and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-gmbh/1a21338f-3f91-4c82-9a4c-eceb0e53d182/