# China NMPA Product Recall - sound processor

Source: https://www.globalkeysolutions.net/records/china_product_recall/cochlear-bone-anchored-solutions-ab/3651ec93-f9e4-4931-b419-3d72ece6baa5/
Source feed: China

> China NMPA product recall for sound processor by Cochlear Bone Anchored Solutions AB published June 12, 2019. Recall level: Level 3 Recall. Cochlear Bone Anchored Solutions AB initiated a voluntary Class III recall of its sound processor (R

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cochlear Bone Anchored Solutions AB proactively recalls sound processors.
- Company Name: Cochlear Bone Anchored Solutions AB
- Publication Date: 2019-06-12
- Product Name: sound processor
- Recall Level: Level 3 Recall
- Recall Reason: The products in question may have labeling errors.
- Discovering Company: Aucler Medical Devices (Beijing) Co., Ltd.
- Manufacturing Company: Cochlear Bone Anchored Solutions AB
- Summary: Cochlear Bone Anchored Solutions AB initiated a voluntary Class III recall of its sound processor (Registration Certificate No.: 20182461914). This action was reported by Cochlear Medical Devices (Beijing) Co., Ltd. and publicly announced by the National Medical Products Administration (NMPA) on June 12, 2019. The basis for this proactive market withdrawal is a potential labeling error identified with the device. The NMPA document, indexed as JGXX-2019-10377, outlines the details of this medical device recall event. A Class III recall signifies that while an issue exists, the use of or exposure to the affected product is not likely to cause adverse health consequences. The company is taking appropriate steps to address the identified discrepancy. Comprehensive information concerning affected product models, specifications, and batch numbers is provided in the "Medical Device Recall Event Report Form," which accompanies the NMPA's public notification. This recall highlights the NMPA's regulatory function in upholding the accuracy and safety standards for medical devices circulated within its jurisdiction.

Company: https://www.globalkeysolutions.net/companies/cochlear-bone-anchored-solutions-ab/d9868610-3d30-472e-b6a3-be88114e0147/