# China NMPA Product Recall - Camera, endoscopic camera system, endoscopic camera, endoscopic camera device

Source: https://www.keypedia.com/records/china_product_recall/olympus-medical-corporation/d4a84ec9-9962-4323-a749-4d120f14cdb6
Source feed: China

> China NMPA product recall for Camera, endoscopic camera system, endoscopic camera, endoscopic camera device by Olympus Medical Corporation published November 17, 2023. Recall level: Level 2 Recall. Olympus Medical Corporation, through its subsidiary Olympus Trading (Shanghai) Co., Ltd., has initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation is voluntarily recalling cameras, endoscopic camera systems, endoscopic cameras, and endoscopic camera devices.
- Company Name: Olympus Medical Corporation
- Publication Date: 2023-11-17
- Product Name: Camera, endoscopic camera system, endoscopic camera, endoscopic camera device
- Recall Level: Level 2 Recall
- Recall Reason: The product in question failed to apply adhesive to the specific location of the camera during the repair process.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: Olympus Medical Corporation, through its subsidiary Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Level II recall of several medical devices. This action, published by the National Medical Products Administration (NMPA) on November 17, 2023, addresses critical manufacturing and repair deficiencies. The recall involves various cameras, endoscopic camera systems, and endoscopic camera devices, identified by specific national medical device registration certificates. The primary issues stem from two distinct problems: the failure to adequately remove adhesive residue during the repair process of affected products, and the application of a sealant to unauthorized locations on certain cameras. These violations indicate a potential compromise in the product quality and safety standards. The NMPA's classification of this as a Level II recall signifies 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. Detailed information regarding the specific models, specifications, and batches subject to this recall is available in the "Medical Device Recall Event Report Form" submitted by Olympus. This proactive measure by Olympus under the NMPA's regulatory framework aims to mitigate potential risks to patients and healthcare professionals.

Company: https://www.keypedia.com/companies/olympus-medical-corporation/527e2e59-6901-42c2-a360-40be55f6edb8