问题 问答题 简答题

不认真履行召回义务,将受何种处罚?

答案

参考答案:

医疗器械生产企业发现医疗器械存在缺陷而没有主动召回或者拒绝召回医疗器械的,责令召回医疗器械,并处应召回医疗器械货值金额3倍的罚款;造成严重后果的,吊销医疗器械产品注册证书,直至吊销医疗器械生产许可证。

对于以下情形,予以警告,责令限期改正,并处3万元以下罚款:未在规定时间内将召回医疗器械的决定通知到医疗器械经营企业、使用单位或者告知使用者的;未按照食品药品监督管理部门要求采取改正措施或者重新召回医疗器械的;未对召回医疗器械的处理做详细记录或者未向食品药品监督管理部门报告的。

对于以下情形,予以警告,责令限期改正;逾期未改正的,处3万元以下罚款:未按规定建立医疗器械召回制度的;拒绝协助食品药品监督管理部门开展调查的;未按规定提交《医疗器械召回事件报告表》、调查评估报告和召回计划、医疗器械召回计划实施情况和总结报告的;变更召回计划,未报食品药品监督管理部门备案的。

阅读理解与欣赏
单项选择题


PASSAGE 1
To Err Is Human
by Lewis Thomas
Everyone must have had at least one personal experience with a computer error by this time. Bank balances are suddenly reported to have jumped from $379 into the millions, appeals for charitable contributions are mailed over and over to people with crazy sounding names at your address, department stores send the wrong bills, utility companies write that they’re turning everything off, that sort of thing. If you manage to get in touch with someone and complain, you then get instantaneously typed, guilty letters from the same computer, saying, "Our computer was in error, and an adjustment is being made in your account."
These are supposed to be the sheerest, blindest accidents. Mistakes are not believed to be the normal behavior of a good machine. If things go wrong, it must be a personal, human error, the result of fingering, tampering a button getting stuck, someone hitting the wrong key. The computer, at its normal best, is infallible.
I wonder whether this can be true. After all, the whole point of computers is that they represent an extension of the human brain, vastly improved upon but nonetheless human, superhuman maybe. A good computer can think clearly and quickly enough to beat you at chess, and some of them have even been programmed to write obscure verse. They can do anything we can do, and more besides.
It is not yet known whether a computer has its own consciousness, and it would be hard to find out about this. When you walk into one of those great halls now built for the huge machines, and standing listening, it is easy to imagine that the faint, distant noises are the sound of thinking, and the turning of the spools gives them the look of wild creatures rolling their eyes in the effort to concentrate, choking with information. But real thinking, and dreaming, are other matters. On the other hand, the evidence of something like an unconscious, equivalent to ours, are all around, in every mail. As extensions of the human brain, they have been constructed the same property of error, spontaneous, uncontrolled, and rich in possibilities.

The author compared the faint and distant sound of the computer to the sound of thinking and regarded it as the product of

A.dreaming and thinking.

B.some property of errors.

C.consciousness.

D.possibilities.