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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It was identified that there is potential that a possible position sensor fault in the swivel base axis is not being detected by the system software. following the enabling of movement by the operator the c-arm system can unexpectedly move faster than normal. please note that the system will not move without movement being initiated by the operator however the speed at which it can move would be faster than normal.
Model Catalog: 10848282 (Lot serial: SOFTWARE VERSION VD10E); Model Catalog: 10848280 (Lot serial: SOFTWARE VERSION VD10E); Model Catalog: 10094141 (Lot serial: SOFTWARE VERSION VB21B); Model Catalog: 10094139 (Lot serial: SOFTWARE VERSION VC14J VB21B); Model Catalog: 10094135 (Lot serial: SOFTWARE VERSION VC14J VB21B); Model Catalog: 10848353 (Lot serial: SOFTWARE VERSION VD10E)