GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for

FDA device recall Z-2236-2016 · posted 2016-07-23 · Terminated

Recall details

Recalling firm

GE Inspection Technologies, LP

Reason for recall

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

RCE

Quantity affected

4

Distribution

US Distribution to the states of : FL, TN, and TX.

Date initiated

2016-03-02

Date posted

2016-07-23

Date terminated

2017-08-07

Location

Lewistown, PA