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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Speakers in vsm300 vital signs monitor failed to produce sound. the failure of the speaker eliminates audio alarm tones for parameter violation equipment alerts or error codes as well as repetitive beeps to indicate pulses when monitoring sp02 (oximetry).
Model Catalog: 5300P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5300P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-F1 (Lot serial: