# China NMPA Product Recall - Naida CI Q30 sound processor, Naida CI Q70 sound processor, Naida CI Q90 sound processor

Source: https://www.globalkeysolutions.net/records/china_product_recall/advanced-bionics-ag/73330365-24ec-4111-8037-a24f016bb1e6
Source feed: China

> China NMPA product recall for Naida CI Q30 sound processor, Naida CI Q70 sound processor, Naida CI Q90 sound processor by Advanced Bionics AG published March 11, 2019. Recall level: Level 3 Recall. Advanced Bionics AG, the manufacturer, initiated a voluntary Level III recall of its Naida CI sound 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Advanced Bionics AG initiates a recall of its sound processors.
- Company Name: Advanced Bionics AG
- Publication Date: 2019-03-11
- Product Name: Naida CI Q30 sound processor, Naida CI Q70 sound processor, Naida CI Q90 sound processor
- Recall Level: Level 3 Recall
- Recall Reason: Two sound processors pre-installed with Naida CIQ70 firmware were mistakenly labeled as Naida CI Q90. Following the discovery of this error, records for all 111,713 Naida CI sound processors were investigated, revealing eight affected processors. Although these devices do not pose a risk to user safety or health, Leading Bionics AG of Switzerland has decided to contact users to replace their devices.
- Discovering Company: Leading Bionic Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Advanced Bionics AG
- Summary: Advanced Bionics AG, the manufacturer, initiated a voluntary Level III recall of its Naida CI sound processors due to a labeling error. This recall, reported to the National Medical Products Administration (NMPA) and its provincial food and drug administration department on February 25, 2019, and officially published on March 11, 2019, addresses a discrepancy where two sound processors pre-installed with Naida CI Q70 firmware were incorrectly labeled as Naida CI Q90. The affected products include specific models like Naida CI Q30, Q70, and Q90 sound processors, with eight units identified by unique identification information. While the company stated that this error poses no risk to user safety or health, Advanced Bionics AG, with its agent Leading Bionics Medical Devices (Shanghai) Co., Ltd., decided to undertake corrective actions. The required actions involve contacting users to provide new, correctly labeled sound processors as replacements for the eight affected devices. The returned units will undergo quarantine and proper disposal. Importantly, all affected devices were identified before shipment to China, ensuring that domestic customers are not impacted by this recall. The regulatory framework for this recall falls under the NMPA's medical device oversight.

Company: https://www.globalkeysolutions.net/companies/advanced-bionics-ag/f44faa9b-a315-45fa-92f3-cea6befa6723