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.
One of the three pins that is used to hold the ort200 table alignment block in place on the floor of the mr suite went missing during testing at a health care facility.
조치
Consignees were sent on 10/01/2014 an IMRIS "Urgent Field Safety Notice" letter dated September 25, 2014. The letter described the problem and the product involved in the recall. The letter informed consignees that the pins will be replaced with pins made of non-ferrous material. Customers are to ensure that users are aware of the changes and the existing procedure for table alignment and managing ferrous content in the magnet room. Contact customer support at 1-866-475-0525 for questions.
Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
제품 설명
IMRIS Operating Room table (ORT200 and ORT300). || Intended for use during diagnostic examinations or surgical procedures to support and position a patient.