# China NMPA Product Recall - Digital Medical Imaging System for Urology - 80KW High Voltage Generator

Source: https://www.globalkeysolutions.net/records/china_product_recall/liebel-flarsheim-company/5572a33c-7d0e-4b1a-88ab-4d4561e62344/
Source feed: China

> China NMPA product recall for Digital Medical Imaging System for Urology - 80KW High Voltage Generator by Liebel-Flarsheim Company published July 21, 2010. Recall level: . The National Medical Products Administration (NMPA) issued a recall report on July 21, 2010, regardi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Report Form for Urology Digital Medical Imaging System - 80KW High Voltage Generator
- Company Name: Liebel-Flarsheim Company
- Publication Date: 2010-07-21
- Product Name: Digital Medical Imaging System for Urology - 80KW High Voltage Generator
- Recall Reason: The system malfunctioned, and the smoke caused the generator to stop working, emitting a burnt smell and/or smoke from the X-ray generator.
- Discovering Company: Covidien
- Manufacturing Company: Liebel-Flarsheim Company
- Summary: The National Medical Products Administration (NMPA) issued a recall report on July 21, 2010, regarding an 80KW High Voltage Generator, model SHF-835, utilized within Digital Medical Imaging Systems for Urology. The generator, produced by Liebel-Flarsheis Company and distributed by its Beijing Representative Office, was found to have critical malfunctions. Reports indicated system failures characterized by smoke emission, a burning smell, and complete generator malfunction during operation. The recall specifically targeted one unit sold in China, with serial number G29230, which was part of a broader sales period between February 13, 2008, and June 2, 2010. In response to these serious operational and safety concerns, Covidien initiated a comprehensive corrective action plan on June 14, 2010. This plan was executed with full awareness of both NMPA directives and relevant U.S. Food and Drug Administration (FDA) regulations, underscoring a commitment to international safety standards. The primary required action was an immediate instruction to customers to cease all radiology and fluoroscopy applications using the affected system. Furthermore, it mandated that the system undergo calibration by a qualified maintenance engineer before any further use. At the time of the report, the calibration efforts were actively underway, ensuring prompt remediation of the identified product defect.

Company: https://www.globalkeysolutions.net/companies/liebel-flarsheim-company/03789a8a-27aa-4f60-87b5-46fd00555c42/