U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Biopsy needle guide kit - Product Code OIJ
원인
The firm is implementing a product correction involving its affirm¿ lateral arm upright biopsy accessory, asy-09880. the correction has been initiated due to a component (the left-hand guide or the blue needle guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. this may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. this impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. there are no known instances of illness or injury.