# China NMPA Product Recall - Subcutaneous Implantable Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/9c0dc586-92f9-48a7-a2c4-67f7690a7e96/
Source feed: China

> China NMPA product recall for Subcutaneous Implantable Defibrillator by Boston Scientific Corporation published December 16, 2022. Recall level: Level 2. Boston Scientific Corporation has initiated a voluntary Class II recall of specific models and batch

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation is voluntarily recalling its subcutaneous implantable defibrillator.
- Company Name: Boston Scientific Corporation
- Publication Date: 2022-12-16
- Product Name: Subcutaneous Implantable Defibrillator
- Recall Level: Level 2
- Recall Reason: An incorrect date and timestamp in the software of a subcutaneous implantable cardioverter defibrillator may cause problems displaying the remaining battery level.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation has initiated a voluntary Class II recall of specific models and batches of its Subcutaneous Implantable Defibrillator. This action, reported by Boston Scientific International Medical Trade (Shanghai) Co., Ltd., was announced on December 16, 2022, under the oversight of the National Medical Products Administration (NMPA). The recall stems from a critical software anomaly within the device.The primary issue identified is a date and timestamp error in the defibrillator's software. This defect may lead to an inaccurate display of the remaining battery power, potentially impacting the device's operational reliability and user confidence. While the document does not detail specific inspection dates, the voluntary recall signifies the company's proactive response to address this product deficiency once identified.Under the NMPA's regulatory framework, a Class II recall indicates a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Boston Scientific Corporation is taking responsibility for the affected devices, documented in a "Medical Device Recall Event Report Form." This recall ensures the integrity and safety of medical devices in the market by addressing the software flaw that could mislead users about the device's remaining power. The company is expected to implement corrective measures to prevent recurrence and restore product integrity.

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