# China NMPA Product Recall - Excimer Laser System

Source: https://www.globalkeysolutions.net/records/china_product_recall/carl-zeiss-meditec-ag-germany/cfacf67e-d281-4e98-8348-d262e7272f5e/
Source feed: China

> China NMPA product recall for Excimer Laser System by Carl Zeiss Meditec AG (Germany) published October 17, 2024. Recall level: Level 2 Recall. Carl Zeiss Meditec AG has initiated a voluntary recall of its Excimer Laser systems. This action was

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carl Zeiss Meditec AG Medical Technologies (Germany) Co., Ltd. is voluntarily recalling products including excimer laser systems.
- Company Name: Carl Zeiss Meditec AG (Germany)
- Publication Date: 2024-10-17
- Product Name: Excimer Laser System
- Recall Level: Level 2 Recall
- Recall Reason: Because it incorporates PRK (laser-assisted refractive keratomileusis) and PTK (therapeutic surface keratomileusis) functions that have not yet been approved in Japan.
- Discovering Company: Carl Zeiss (Shanghai) Management Co., Ltd.
- Manufacturing Company: Carl Zeiss Meditec AG (Germany)
- Summary: Carl Zeiss Meditec AG has initiated a voluntary recall of its Excimer Laser systems. This action was reported to the National Medical Products Administration (NMPA) in China by Carl Zeiss (Shanghai) Management Co., Ltd. The primary reason for the recall is the inclusion of specific functionalities, namely PRK (laser-assisted refractive keratomileusis) and PTK (therapeutic surface keratomileusis), which have not yet received regulatory approval in Japan for these devices. The recall references National Medical Device Registration Certificates 20153163346 and 20153243346, operating within the NMPA's regulatory framework. While the document does not specify inspection dates, it outlines a proactive measure by the manufacturer to address this regulatory discrepancy. A critical detail for the Chinese market is that the specific products subject to this recall were not imported into China, indicating no direct impact on patients or healthcare providers within the country. The required action is a voluntary withdrawal of these devices, with comprehensive details on affected models, specifications, and batches provided in an accompanying Medical Device Recall Event Report Form. This recall highlights the company's commitment to ensuring product compliance with various regional regulatory standards.

Company: https://www.globalkeysolutions.net/companies/carl-zeiss-meditec-ag-germany/c8ea2733-1e5d-469f-83e3-77c4180d4d9d/