# China NMPA Product Recall - Diagnostic Ultrasound System

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-medical-solut-inc-inc/4e1235ca-8a4a-4ee6-9d1f-08bea8576e31/
Source feed: China

> China NMPA product recall for Diagnostic Ultrasound System by Siemens Medical Solut Inc., Inc. published August 04, 2023. Recall level: Level 2 Recall. Siemens Medical Solutions USA, Inc. has initiated a voluntary Class II recall for its Diagnostic Ult

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Solutions USA, Inc. is voluntarily recalling its ultrasound diagnostic systems.
- Company Name: Siemens Medical Solut Inc., Inc.
- Publication Date: 2023-08-04
- Product Name: Diagnostic Ultrasound System
- Recall Level: Level 2 Recall
- Recall Reason: Potential issues exist in certain software versions of the ACUSON Redwood system.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Medical Solut Inc., Inc.
- Summary: Siemens Medical Solutions USA, Inc. has initiated a voluntary Class II recall for its Diagnostic Ultrasound System, specifically involving a particular software version of the ACUSON Redwood system. This action, reported by Siemens Medical Solutions, Inc., was published by the National Medical Products Administration (NMPA) on August 4, 2023. The recall addresses a potential software problem identified within the affected devices. As a required action, the company is voluntarily recalling the implicated systems to mitigate any potential risks associated with the software issue. The regulatory framework for this recall is established by the NMPA. Further detailed information, including affected product models, specifications, and batch numbers, is available in the "Medical Device Report Form" and an attached "Medical Device Recall Event Report Form." This proactive measure by Siemens Medical Solutions USA, Inc., also associated with Siemens Healthineers, highlights their commitment to maintaining product safety and quality in compliance with regulatory standards. The Class II designation indicates that the identified issue could lead to temporary or reversible adverse health consequences, with the probability of serious consequences being remote.

Company: https://www.globalkeysolutions.net/companies/siemens-medical-solut-inc-inc/f0a3c028-72af-4155-89ec-d354c5f1a8a1/