# China NMPA Product Recall - Diagnostic Ultrasound System and Transducers

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-ultrasound-inc/c65bb5fb-2d38-4e2f-99bc-815afae36d59/
Source feed: China

> China NMPA product recall for Diagnostic Ultrasound System and Transducers by Philips Ultrasound, Inc. published August 25, 2021. Recall level: Level 2 Recall. Philips Ultrasound, Inc. has initiated a voluntary Class II recall for specific Diagnostic Ultrasoun

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Ultrasound, Inc. is voluntarily recalling its Diagnostic Ultrasound System and Transducers.
- Company Name: Philips Ultrasound, Inc.
- Publication Date: 2021-08-25
- Product Name: Diagnostic Ultrasound System and Transducers
- Recall Level: Level 2 Recall
- Recall Reason: Due to a software defect, EPIQ and EPIQAFFINITI ultrasound systems experienced a response (lock) when reviewing or adjusting xPlane examination results, hindering users from continuing clinical use.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Ultrasound, Inc.
- Summary: Philips Ultrasound, Inc. has initiated a voluntary Class II recall for specific Diagnostic Ultrasound System and Transducers, a measure publicly announced by the National Medical Products Administration (NMPA) on August 25, 2021. This action, reported to the NMPA by Philips (China) Investment Co., Ltd., stems from a critical software defect affecting designated models, specifically the EPIQ and EPIQAFFINITI ultrasound systems, across certain manufacturing batches. The identified issue manifests as a system unresponsiveness or "lock-up" that occurs when clinicians attempt to review or adjust xPlane test results. This malfunction directly impairs the systems' functionality, preventing uninterrupted clinical use and potentially impacting diagnostic workflow. The voluntary recall serves as the company's required corrective action under the NMPA's regulatory oversight to address this technical anomaly. By recalling the affected products, Philips Ultrasound, Inc. aims to mitigate potential operational risks and uphold device reliability and patient safety standards. Comprehensive details regarding the affected product models, specifications, and batches are provided in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/philips-ultrasound-inc/879d9f04-50c3-42b3-8196-4377eba021c1/