# China NMPA Product Recall - Fiberoptic hysteroscopy with flexible hysteroscopy

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/6847dd2d-e0b7-46e9-b4db-071e26c5c15d/
Source feed: China

> China NMPA product recall for Fiberoptic hysteroscopy with flexible hysteroscopy by Olympus Medical Corporation published July 04, 2023. Recall level: Level 3 Recall. Olympus Medical Corporation, in conjunction with Olympus Trading (Shanghai) Co., Ltd., has initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation initiates voluntary recall of flexible fiber optic hysteroscopes.
- Company Name: Olympus Medical Corporation
- Publication Date: 2023-07-04
- Product Name: Fiberoptic hysteroscopy with flexible hysteroscopy
- Recall Level: Level 3 Recall
- Recall Reason: Changes were not initiated due to the label and packaging insert for the MD-159 attraction button.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: Olympus Medical Corporation, in conjunction with Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its flexible hysteroscope (model number 20172061609). The recall stems from a procedural lapse where necessary changes to the label and packaging insert for the MD-159 suction button component were not implemented as required. This oversight led to non-compliance with regulatory standards for medical device labeling. The National Medical Products Administration (NMPA) of China published details of this recall on July 4, 2023, indicating that the manufacturer reported the issue and is taking corrective action. The recall specifically targets affected product models, specifications, and batch numbers as detailed in the accompanying "Medical Device Recall Event Report Form." This action underscores the importance of stringent change control processes for medical device components and documentation to ensure patient safety and regulatory adherence within the medical device industry.

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