# China NMPA Product Recall - Fiberoptic bronchoscopy (flexible bronchoscope), fiberoptic nasopharyngoscopy (flexible nasopharyngoscopy)

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/112ce596-0af2-45f3-9b4c-1a99c2ad7e1f/
Source feed: China

> China NMPA product recall for Fiberoptic bronchoscopy (flexible bronchoscope), fiberoptic nasopharyngoscopy (flexible nasopharyngoscopy) by Olympus Medical Corporation published November 14, 2022. Recall level: Level 3 Recall. Olympus Medical Corporation, via its subsidiary Olympus Trading (Shanghai) Co., Ltd., has initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation is voluntarily recalling its flexible bronchoscope and flexible nasopharyngoscope.
- Company Name: Olympus Medical Corporation
- Publication Date: 2022-11-14
- Product Name: Fiberoptic bronchoscopy (flexible bronchoscope), fiberoptic nasopharyngoscopy (flexible nasopharyngoscopy)
- Recall Level: Level 3 Recall
- Recall Reason: The specifications in the instruction manual are inconsistent with those at the time of registration.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: Olympus Medical Corporation, via its subsidiary Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of specific models and batches of its flexible fiberoptic bronchoscope and flexible fiberoptic nasopharyngoscope. This action, reported to the National Medical Products Administration (NMPA) on November 14, 2022, addresses a critical discrepancy. The main issue identified is an inconsistency between the product specifications detailed in the instruction manuals and the information filed within the official registration certificates (Nos. 20182222197 and 20182062576).

While the document does not specify inspection dates, the recall is a proactive measure by the company to rectify this non-conformance. The regulatory framework under which this recall is managed is the NMPA, which oversees medical device safety and compliance in China. A Class III classification typically signifies a situation where use of or exposure to a product is not likely to cause adverse health consequences.

The required action by Olympus involves the comprehensive recall of the affected medical devices to ensure that all product documentation accurately reflects the registered information, thereby maintaining product integrity and user safety. This voluntary recall underscores the company's commitment to compliance with NMPA regulations regarding medical device specifications and user instructions.

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