All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F;) Systems 의 리콜

Recall

RC-2015-RN-00573-1

Class II

2015-06-26

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00573-1

The spot film device (sfd)/ intelligent digital device (idd) safety mechanism installed on the above systems may not engage properly at the lower range of sfd/idd travel. this mechanism is installed to hold and prevent the sfd/idd from falling due to a counterweight cable failure. the lower range of travel is 1.1” (28mm) from the lowest point of normal sfd/idd vertical compression. a fall of the sfd/idd could result in an injury to a patient or operator. there have been no reported injuries as a result of this issue.

GE Healthcare will correct all affected products. A GE Healthcare representative will contact you to arrange for the correction. The system can continue to be used provided end users: - Perform preventative maintenance in accordance with your product labeling. This includes inspection of the counterweight cables and pulleys every 6 month, and replacement of the counterweight cables every four years. - Set the manual Myelographic stop on the fluoroscopy carriage during exams. This action has been closed-out on 05/08/2016.