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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원인
Early failure of the neoblue blanket system fiberoptic pads. these failures involved discoloration/degradation followed by eventual melting of the fiberoptic cable end that is inserted in the neoblue blanket light box.
Model Catalog: 006895 (Lot serial: all lots. contact manufacturer); Model Catalog: 006244 (Lot serial: all lots. contact manufacturer); Model Catalog: 006254 (Lot serial: all lots. contact manufacturer)
제품 설명
neoBLUE blanket LED Phototherapy Systems;neoBLUE blanket LED Light Box