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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Edwards lifesciences has initiated a voluntary safety alert regarding the ev1000a system to reinforce the proper set up of the external power supply according to the equipment's operator manual. the company received a recent event of an electrical fire therefore is sending a notice to all customers with ev1000a systems installed to confirm installation against the current requirements documented in the operator's manual section ev1000 power adapter mounting bracket.
Model Catalog: EVVVTC1 (Lot serial: ALL); Model Catalog: EVPSA1 (Lot serial: ALL); Model Catalog: EV1000A (Lot serial: ALL); Model Catalog: EVDBB1 (Lot serial: ALL); Model Catalog: EVFTC1 (Lot serial: ALL); Model Catalog: EVFTCL (Lot serial: ALL); Model Catalog: EVEC1 (Lot serial: ALL); Model Catalog: EVECL (Lot serial: ALL); Model Catalog: EVDBA1 (Lot serial: ALL); Model Catalog: EVPCA1 (Lot serial: ALL)
제품 설명
EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODIULTION CABLE;EDWARDS EV1000 SYSTEM - BIFURCATED POWER SUPPLY;EDWARDS EV1000 SYSTEM - MONITOR;EDWARDS EV1000 SYSTEM - FLOTRAC CABLE;EDWARDS EV1000 SYSTEM - ETHERNET CABLE;EDWARDS EV1000 SYSTEM - POWER ADAPTER;EDWA