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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01078-1
Product Name/Description	IMRIS Operating Room table (ORT300) Model number: 114093-000 Lot numbers: 10002255 ARTG number: 206814
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	7/10/2014
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	Emergo Australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material due to an incident at a health care facility in the United States. 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 and was not accounted for by OR personnel. During testing the missing pin was pulled into the magnet, damaging the image quality phantom and headrest extension. No injury or death occurred as a result of this incident.
Recall Action	Recall for Product Correction
Recall Action Instructions	Emergo Australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material. A field engineer will be sent to the customer site to replace the pins. This action has been closed-out on 06/06/2016.
Contact Information	02 9006 1662 - Emergo Australia