Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
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, based on matches of recall data from the U.S. and Canada.
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Carestream health has identified an issue with the drx-revolution mobile x-ray system that could result in unintended motion. carestream's investigation found that the pivot screws in the drive handle can back out and interfere with the driving mechanism. the backed out screw can interfere with operator control of the drx revolution and result in unintended motion. the investigation revealed that thread locking compound applied in the manufacturing process to secure this screw was not always applied as it should. to date carestream has found only a single system where this failure has occurred there was no resulting injury but the problem could manifest in additional units over the life of the device.