# China NMPA Product Recall - Holmium (HoY:AG) Laser Surgical System

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/457c48ab-a9bb-414c-b163-4f8d3e23c36c/
Source feed: China

> China NMPA product recall for Holmium (HoY:AG) Laser Surgical System by Boston Scientific Corporation published May 16, 2019. Recall level: Level 2. Boston Scientific Corporation initiated a Class II voluntary recall of its Holmium (HoY:AG) laser su

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation is voluntarily recalling its holmium (HoY:AG) laser surgical system.
- Company Name: Boston Scientific Corporation
- Publication Date: 2019-05-16
- Product Name: Holmium (HoY:AG) Laser Surgical System
- Recall Level: Level 2
- Recall Reason: Boston Scientific is recalling its Auriga30 and AurigaXL4007 holmium laser surgical systems due to a problem with the mechanical cooling system that could cause low power output errors. Our analysis of complaints regarding the holmium laser surgical systems revealed that some heat exchangers from supplier Kelvion-Catoosa may be contaminated. Contaminated heat exchangers can allow particles to enter the water supply system and subsequently the resonant cavity, leading to reduced resonant cavity energy and causing the main unit to perform below expectations. In the worst-case scenario, low power output can delay surgery and render the equipment unusable.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation initiated a Class II voluntary recall of its Holmium (HoY:AG) laser surgical systems, specifically models Auriga30 and AurigaXL4007. This action was reported to the National Medical Products Administration (NMPA) on April 11, 2019, with the NMPA publishing the details on May 16, 2019. The core issue stemmed from a potential low-energy output error traced to a mechanical cooling system malfunction. Analysis revealed that heat exchangers from a supplier, Kelvion-Catoosa, were contaminated. This contamination could introduce particles into the system's water supply and resonant cavity, leading to a reduction in energy output. Such a malfunction could delay surgical procedures and potentially render the equipment inoperable, posing risks in urinary tract soft tissue and stone treatments. While Boston Scientific Corporation, the manufacturer, initiated the global recall, its Chinese agent, Boston Scientific International Medical Trading (Shanghai) Co., Ltd., confirmed that no affected products were imported or sold in China. Consequently, within the Chinese regulatory framework, the agent's only required action was to report the incident to the NMPA, with no further recall measures, investigations, or reports necessary.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/