# China NMPA Product Recall - Rigid fiber mammoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/schoelly-fiberoptic-gmbh/b24ccf42-e816-43e5-8973-1c969ee4b49a/
Source feed: China

> China NMPA product recall for Rigid fiber mammoscope by Schoelly Fiberoptic GmbH published August 15, 2022. Recall level: . Schoelly Fiberoptic GmbH, supported by Schoelly (Guangzhou) Endoscopy Technology Co., Ltd., has init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Schoelly Fiberoptic GmbH is voluntarily recalling rigid fiber mammoscopes.
- Company Name: Schoelly Fiberoptic GmbH
- Publication Date: 2022-08-15
- Product Name: Rigid fiber mammoscope
- Recall Reason: A fiberoptic breast endoscope with incomplete components, lacking an operating handle (manual), is not considered a complete medical device product for sale.
- Discovering Company: Xueli (Guangzhou) Endoscopic Technology Co., Ltd.
- Manufacturing Company: Schoelly Fiberoptic GmbH
- Summary: Schoelly Fiberoptic GmbH, supported by Schoelly (Guangzhou) Endoscopy Technology Co., Ltd., has initiated a voluntary recall of its rigid fiber mammoscope, specifically batch number 202204. This action followed an internal inspection which identified that the distributed medical devices had incomplete components. The product's registration certificate explicitly states that the device comprises an endoscope, a sheath, and an operating handle; however, units from the affected batch were found to be missing the operating handle. Although the operating handle's purpose is to shorten the ductoscope's length, Schoelly Fiberoptic GmbH has affirmed that its absence does not impact the overall safety or effectiveness of the product, and no patient injuries have been reported. This recall is being managed under the regulatory framework of the National Medical Products Administration (NMPA), with detailed information on affected models and specifications provided in a Medical Device Recall Event Report Form. The company is taking these required actions to ensure adherence to regulatory standards concerning product completeness.

Company: https://www.globalkeysolutions.net/companies/schoelly-fiberoptic-gmbh/fd20cb0e-81e5-489b-a5e2-4563b13fda9f/