# China NMPA Product Recall - Ultrasound diagnostic system

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/15678599-322f-4254-a870-ad8c9825f318/
Source feed: China

> China NMPA product recall for Ultrasound diagnostic system by Siemens Healthineers Co., Ltd. published February 13, 2019. Recall level: Level 2 Recall. On February 13, 2019, Siemens Healthineers, specifically Siemens Medical Systems Ltd., announced a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers has initiated a voluntary recall of its ultrasound diagnostic systems.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2019-02-13
- Product Name: Ultrasound diagnostic system
- Recall Level: Level 2 Recall
- Recall Reason: When performing pulsed wave Doppler under specific imaging conditions, the probe may exceed the orbital 3 and acoustic output power (AOP) values, which may lead to cavitation and thus the risk of burns or tissue damage.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: On February 13, 2019, Siemens Healthineers, specifically Siemens Medical Systems Ltd., announced a voluntary Class II recall of its ultrasound diagnostic systems, overseen by the National Medical Products Administration (NMPA). This action follows an internal discovery during ongoing quality improvement efforts. It was identified that under certain imaging conditions, when performing pulse wave Doppler, the ultrasound probe might intermittently exceed permissible orbital 3 and acoustic output power (AOP) values. While the likelihood of this issue occurring is extremely low, and the possibility of adverse outcomes such as cavitation, burns, or tissue damage remains very remote, Siemens has prioritized patient safety by initiating this recall. Crucially, the company has not received any reports of injuries or adverse events associated with this specific problem. The recall applies to ultrasound diagnostic systems registered under certificate numbers 20172230583 and 20182230177. As a required action under the NMPA's framework, Siemens Medical Systems Ltd. is retrieving these devices. Further comprehensive details regarding the specific affected product models, specifications, and batches are provided in an accompanying "Medical Device Recall Event Report Form." This proactive measure underscores Siemens Healthineers' commitment to maintaining high product quality and ensuring compliance with medical device safety regulations.

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/