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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R series may display an ecg fault 7 message and fail to display the ecg baseline. failure to display the patient's ecg could delay delivery of defibrillation or pacing therapy.
Model Catalog: ZOLL R SERIES (Lot serial: S/N AF09B006789); Model Catalog: ZOLL R SERIES (Lot serial: S/N AF09B006791); Model Catalog: ZOLL R SERIES (Lot serial: S/N AF08L006574); Model Catalog: ZOLL R SERIES (Lot serial: S/N AF08J005776); Model Catalog: ZOLL R SERIES (Lot serial: S/N AF08G005269); Model Catalog: ZOLL R SERIES (Lot serial: S/N AF07F001253)