# China NMPA Product Recall - Carbon dioxide laser therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-jiading-optoelectronic-instruments-co-ltd/91d69570-302e-4944-b144-38cb4e995842/
Source feed: China

> China NMPA product recall for Carbon dioxide laser therapy device by Shanghai Jiading Optoelectronic Instruments Co., Ltd. published October 18, 2018. Recall level: Level 3 Recall. In October 2018, Shanghai Jiading Optoelectronic Instrument Co., Ltd. announced a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Jiading Optoelectronic Instruments Co., Ltd. voluntarily recalls carbon dioxide laser therapy devices.
- Company Name: Shanghai Jiading Optoelectronic Instruments Co., Ltd.
- Publication Date: 2018-10-18
- Product Name: Carbon dioxide laser therapy device
- Recall Level: Level 3 Recall
- Recall Reason: The actual laser value measured on the working surface of the product may be less than the set value; the actual wavelength may be lower than the product standard requirements.
- Discovering Company: Shanghai Jiading Optoelectronic Instruments Co., Ltd.
- Manufacturing Company: Shanghai Jiading Optoelectronic Instruments Co., Ltd.
- Summary: In October 2018, Shanghai Jiading Optoelectronic Instrument Co., Ltd. announced a voluntary Class III recall of its Carbon Dioxide Laser Therapy Device, a measure overseen by the National Medical Products Administration (NMPA). The company initiated this recall after discovering two significant deviations in product performance. Firstly, the actual laser value on the device's working surface was found to be potentially lower than the established set value. Secondly, the measured actual wavelength did not meet the required product standard specifications. These discrepancies are critical as they can compromise the device's efficacy and potentially affect patient treatment outcomes, indicating a failure to consistently meet its design and regulatory performance criteria. The recall encompasses specific models, specifications, and batches of the device, with comprehensive details provided in the "Medical Device Recall Event Report Form" issued by the company. This proactive step by Shanghai Jiading Optoelectronic Instrument Co., Ltd. highlights its responsibility to address product quality and safety concerns, ensuring adherence to NMPA's regulatory framework and maintaining public trust in medical devices. The Class III classification indicates that the product defect is unlikely to cause adverse health consequences, but correction is still necessary for product integrity.

Company: https://www.globalkeysolutions.net/companies/shanghai-jiading-optoelectronic-instruments-co-ltd/07796b89-1d04-4444-8d7c-a56e21112c38/