U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
데이터 추가 비고
Table, operating room, ac powered - Product Code LFQO
원인
A component of the magnus hybrid or system fails to respond to a position command.
조치
Maquet sent a PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION letter dated September 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. To avoid the potential of a malfunction occurring prior to their scheduled Service procedure, customers were instructed to ensure that the MAGNUS table-top is positioned at the "0" pivot position and that the MAGNUS column pivot brake is secured. If it is necessary to pivot the MAGNUS table-top prior to procedure start, ensure that the column pivot brake is completely released and then completely secured when returned to "0" pivot position. Customers were instructed to ensure that all user of the affected product and other necessary persons are informed of the product correction notice.
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