GE Cabinet X-ray systems

FDA device recall Z-0426-2015 · posted 2014-12-17 · Terminated

Recall details

Recalling firm

GE Inspection Technologies, LP

Reason for recall

GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.

Action taken

GE intends to notify its customers of the affected cabinet x-ray systems regarding the warning signs' potential failure to comply with 21 C.F.R. 1020.40(c)(7)(v) through a Technical Information Letter. The notification will inform customers that GE plans to replace the current warning signs with warning signs that comply with the requirements set forth in 21 C.F.R. 1020.40(c)(7)(v). GE will recommend in its notification that it replace the warning sign at the customer's next service interval, but no later than December 31, 2014. For further questions please call (717) 447-1278.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

RCE

Quantity affected

11

Distribution

US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.

Date initiated

2014-11-10

Date posted

2014-12-17

Date terminated

2015-06-29

Location

Lewistown, PA