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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The combined use of the synergy flex-m/shoulder coil 1.5t with other coils increases the chance of rf interaction and heating up of the coil. this may result in possible burns of the patient. this applies to all intera 1.5t and gyroscan intera acs 1.5t mr systems with a synergy flex m/shoulder coil 1.5t initially delivered as release 5.1.7 6 7 8 9 or 10.
Model Catalog: (Lot serial: 5438); Model Catalog: (Lot serial: 5465); Model Catalog: (Lot serial: 5572); Model Catalog: (Lot serial: 99220); Model Catalog: (Lot serial: 5418); Model Catalog: (Lot serial: 5220); Model Catalog: (Lot serial: 5354); Model Catalog: (Lot serial: 22658); Model Catalog: (Lot serial: 8985); Model Catalog: (Lot serial: 10183); Model Catalog: (Lot serial: 8240); Model Catalog: (Lot serial: 10566); Model Catalog: (Lot serial: 8256); Model Catalog: (Lot serial: 10236); Model Catalog: (Lot serial: 8672); Model Catalog: (Lot serial: 8442); Model Catalog: (Lot serial: 8379)