# China NMPA Product Recall - Programmable controller

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/36df9990-7f9a-4839-b681-098e5a922f82/
Source feed: China

> China NMPA product recall for Programmable controller by Boston Scientific Corporation published July 19, 2017. Recall level: . Boston Scientific Corporation, through its subsidiary Boston Scientific International Medical Tradin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation voluntarily recalls programmable controllers.
- Company Name: Boston Scientific Corporation
- Publication Date: 2017-07-19
- Product Name: Programmable controller
- Recall Reason: Radio frequency interference may alter the wireless commands emitted by the programmer to induce the subcutaneous implantable cardioverter defibrillator to execute unexpected commands.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation, through its subsidiary Boston Scientific International Medical Trading (Shanghai) Co., Ltd., issued a voluntary recall of its programmer controllers, formally reported to the National Medical Products Administration (NMPA) on July 19, 2017. This crucial action stems from a identified safety concern: the potential for external radio frequency interference to disrupt and alter the signals emitted by these programmers. Such interference could inadvertently cause subcutaneous implantable cardioverter defibrillators (ICDs) to execute commands not intended by medical professionals, thereby introducing a risk to patient safety. The affected devices, which are critical for programming and managing implanted cardiac devices, are associated with NMPA Registration Certificate No. 20152212429. In response to this potential malfunction, Boston Scientific Corporation proactively initiated a voluntary recall of the specific programmer controllers. Detailed information concerning the precise recall level, affected product models, technical specifications, and relevant batch numbers is comprehensively documented in the "Medical Device Recall Event Report Form" and an accompanying "Voluntary Recall of Programmable Controllers" attachment. This recall highlights the manufacturer's diligence in addressing potential device anomalies to uphold product integrity and ensure patient well-being under the NMPA's regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/