# China NMPA Product Recall - Programmable controller

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-international-medical-trade-shanghai-co-ltd/3484212a-4525-4ae6-ab71-9d57851b68c9/
Source feed: China

> China NMPA product recall for Programmable controller by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. published July 19, 2017. Recall level: Level 2 Recall. Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. voluntarily recalls programmable controllers.
- Company Name: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Publication Date: 2017-07-19
- Product Name: Programmable controller
- Recall Level: Level 2 Recall
- Recall Reason: Radio frequency interference may alter wireless communications from the programmable controller.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Summary: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II medical device recall on July 19, 2017, for certain programmable controllers. The main issue identified is that radio frequency interference has the potential to disrupt or alter the wireless communication signals emitted by these controllers. This communication alteration could impact the proper functioning of the devices, posing a potential risk. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) in China, which serves as the primary regulatory authority for medical devices. A Class II recall indicates that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a required action, Boston Scientific is recalling the affected programmable controllers, identified by Registration No.: 20152212429. Comprehensive details regarding the specific models, product specifications, and batch numbers subject to this recall are provided in an accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/boston-scientific-international-medical-trade-shanghai-co-ltd/bc370948-4fe0-497a-93dd-bbac3a59dd56/