# China NMPA Product Recall - Electronic bronchoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/86e49a4b-ba63-4531-97cc-23efc3457656/
Source feed: China

> China NMPA product recall for Electronic bronchoscope by Olympus Medical Corporation published August 25, 2021. Recall level: Level 2. Olympus Medical Systems Co., Ltd., through its subsidiary Olympus (Shanghai) Co., Ltd., initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation voluntarily recalls electronic bronchoscopes
- Company Name: Olympus Medical Corporation
- Publication Date: 2021-08-25
- Product Name: Electronic bronchoscope
- Recall Level: Level 2
- Recall Reason: During the manufacturing process of the BF-XT160 electronic bronchoscope, there was no adhesive between the endoscope tubing and the insertion tip, and the same fault occurred in the BF-XF160's service kit (NS kit).
- Discovering Company: Olympus (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: Olympus Medical Systems Co., Ltd., through its subsidiary Olympus (Shanghai) Co., Ltd., initiated a voluntary Class II recall of its BF-XT160 electronic bronchoscope and the BF-XF160 repair kit (NS kit). This action, reported on August 25, 2021, to the National Medical Products Administration (NMPA), addresses a critical manufacturing defect. The primary issue identified was the insufficient adhesion between the endoscope tubing and the insertion tip during the production process. This flaw could potentially compromise the safety and functionality of the device during medical procedures. The affected products are associated with Registration Certificate No.: CFDA (Imported) 2006 No. 3220262. The Class II recall designation signifies that 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. Olympus Medical Systems Co., Ltd. is taking responsibility for this manufacturing discrepancy by undertaking this voluntary recall. Further detailed information regarding the specific specifications and batches involved in this recall event is provided in the accompanying "Medical Device Recall Event Report Form" attachment, available on the NMPA website. This measure ensures patient safety and compliance with medical device quality standards.

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