Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
데이터 추가 비고
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
원인
The manufacturer identified that the internal mains does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0.