Device Recall GE Inspection Technologies Phoenix vtomex M240 cabinet xray systems. 의 리콜

Recall

74554

Class 2

Z-2236-2016

2016-03-02

2016-07-23

Terminated

United States

2017-08-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147897

Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. the identified cause was insufficient attachment of shielding in the door. jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.

GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan.