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
Nakanishi updated the operation manual to include clarifications and details regarding the proper maintenance of the handpieces and how proper maintenance can reduce the risk of injury to patients.
Model Catalog: X85L (Lot serial: All Serial #); Model Catalog: Z95L (Lot serial: All Serial #); Model Catalog: M95L (Lot serial: All Serial #); Model Catalog: X95L (Lot serial: All Serial #); Model Catalog: X95EX (Lot serial: All Serial #); Model Catalog: X85 (Lot serial: All Serial #); Model Catalog: X95 (Lot serial: All Serial #); Model Catalog: SGA-E2S (Lot serial: All Serial #); Model Catalog: TI95EX (Lot serial: All Serial #); Model Catalog: Z45L (Lot serial: All Serial #); Model Catalog: SGES (Lot serial: All Serial #); Model Catalog: SGSE2S (Lot serial: All Serial #); Model Catalog: XS93 (Lot serial: All Serial #); Model Catalog: XSG93L (Lot serial: All Serial #); Model Catalog: Z85L (Lot serial: All Serial #); Model Catalog: M95 (Lot serial: All Serial #)
제품 설명
TI-MAX X Contra/HP;TI-MAX Z Contra/HP;S-MAX M Contra/HP;Micro Surgery Handpiece SGA;TI95EX Contra;TI-MAX Z45 Contra;Micro Surgery Handpiece SGS;TI-MAX X-SG Contra