China NMPA Product Recall - X-ray equipment for computed tomography
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The National Medical Products Administration (NMPA) published an announcement on April 29, 2021, detailing a voluntary Class II recall initiated by Siemens Healthcare GmbH. This recall specifically targets X-ray equipment used for computed tomography. The primary reason for this action is a identified software issue that could potentially lead to scanning interruptions in certain models and batches of the devices. Siemens Healthcare Systems Ltd. reported the issue, prompting the manufacturer, Siemens Healthcare GmbH, to proactively recall the affected equipment. The recall encompasses multiple product registration certificate numbers, including 20213060038, 20183300071, 20173301125, 20173301120, 20193061896, and 20183060438. This action, overseen by the NMPA, mandates the company to address the identified flaw to ensure the safety and operational integrity of its medical imaging products. Further details on specific models and batches are available in the accompanying "Medical Device Recall Event Report Form," emphasizing the company's commitment to rectifying potential issues impacting patient care.
- Company
- Siemens Healthcare GmbH
ID · add7b03b-c9e5-45fa-bb4c-d012d8b4886b