The official Food and Drug Administration official website WeChat released a message on March 11th, saying that it received a report from GE Healthcare Trading Development (Shanghai) Co., Ltd. (hereinafter referred to as "General Electric Medical") to recall the "Magnetic Resonance Imaging System". Recalling related MRI systems worldwide due to product defects that could result in serious injury or death.
According to GE Healthcare's report to the Food and Drug Administration, according to the company's knowledge, in some locations, the magnet quenching device in its "magnetic resonance imaging system" may not be connected to the magnet, which will cause the magnet to quench The unit does not function as expected and cannot be quenched by the user when the button is pressed, which can result in serious injury or death. According to the "Administrative Measures for Medical Device Recall (Trial)", if the use of relevant medical devices may or has caused serious health hazards, the medical device manufacturer shall decide to adopt a first-level recall measure, and the first-level recall shall be within 1 day of the company making a recall decision. The basic information, reasons, requirements, and handling methods of the recalled medical devices shall be notified to the relevant medical device operating enterprises, users or users.
The author learned from the Municipal Food and Drug Administration that GE Healthcare has taken a first-level recall measure, and the total number of related products affected in mainland China is 1,196. On January 15, 2015, the company informed the Food and Drug Administration of the medical device recall decision in writing and submitted the “Report on the Medical Device Recall Eventâ€, providing its investigation and evaluation report and recall plan, which was initiated by the company at that time. The recall level is Level 2 (using the medical device may or may have caused temporary or reversible health hazards), and in a re-report on February 25, the company upgraded the recall level to Level 1. At present, the Municipal Food and Drug Administration has reported the relevant information of the first-level recall to the State Food and Drug Administration in a timely manner.
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