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.
데이터 추가 비고
원인
Siemens is initiating a field corrective action as during routine surveillance activities it was identified that contaminants in the form of biomass can develop in the cooling system of artis systems which can result in damage to the pump system. biomass is developing in the ongoing life time of a system.
Model Catalog: 5904656 (Lot serial: 28022); Model Catalog: 7728392 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 5904656 (Lot serial: 28069); Model Catalog: 7007755 (Lot serial: 32070); Model Catalog: 10848283 (Lot serial: NA); Model Catalog: 10848282 (Lot serial: NA); Model Catalog: 10848281 (Lot serial: NA); Model Catalog: 10848280 (Lot serial: NA); Model Catalog: 10848355 (Lot serial: NA); Model Catalog: 10848353 (Lot serial: NA); Model Catalog: 5904441 (Lot serial: NA); Model Catalog: 10280959 (Lot serial: NA); Model Catalog: 5904466 (Lot serial: NA); Model Catalog: 7555357 (Lot serial: 53097); Model Catalog: 7555357 (Lot serial: 53081); Model Catalog: 7555357 (Lot serial: 53088); Model Catalog: 7555357 (Lot serial: 53101); Model Catalog: 5904656 (Lot serial: 28048); Model Catalog: 10094141 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 10094137 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 7727717 (Lot serial: 40033); Model Catalog: 7412807 (Lot serial: 35177); Model Catalog
제품 설명
AXIOM ARTIS BA;ARTIS ZEE BIPLANE;AXIOM ARTIS TA;ARTIS Q;ARTIS Q.ZEN;AXIOM ARTIS FA ALPHA;ARTIS ZEEGO MULTI-AXIS;AXIOM ARTIS MP DIAGNOSTIC;AXIOM ARTIS DBA;ARTIS ZEE CEILING;AXIOM ARTIS DFC MAGNETIC NAVIGATION;AXIOM ARTIS DFC;AXIOM ARTIS FC;AXIOM ARTIS DBC