American quality pacemaker failed to be returned

Release date: 2007-08-24

The quality of the American heart pacemaker failed to be returned. It was learned from the General Administration of Quality Supervision, Inspection and Quarantine that the 272 US-delivered St. Jude heart pacemaker was returned by China's quality inspection department because it was unqualified by China. .
It is understood that at the end of April this year, the Shanghai Entry-Exit Inspection and Quarantine Bureau accepted 272 sets of pacemaker products from St. Jude, USA, with a total value of 236,294 US dollars.
When the inspection and quarantine department detected, it was found that the pulse amplitude detection parameters of the batch of pacemakers did not match the factory parameters of the pulse amplitude, and did not meet the requirements of “the pulse amplitude allowed relative error is not more than 2%” in China's technical standards.
Experts pointed out that the use of cardiac pacemakers that do not meet the standard of the pulse can easily lead to misjudgment of the patient's condition, which will cause serious harm to the patient's life and health. The unqualified American-made cardiac pacemakers have recently been supervised and returned by the entry-exit inspection and quarantine departments. —— Information from: Shanghai Medical Device Industry Association Network

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