Device Recall Phoenix x/ray v/tome/x series 의 리콜

Recall

52193

Class 2

Z-1827-2011

2009-03-16

2011-04-06

Terminated

United States

2017-04-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82489

Some of the systems do not have a safety interlock on the service access panel. although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. also, some systems lack proper placement of a caution label and others do not have this label affixed. two of the systems also lack the sign indicating the meaning of the warning signals.

The firm has completed all of the following necessary actions and no further actions have been indicated: A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062.