Recall Z-1231-2016— GE Inspection Technologies, LP

Name: FDA recall Z-1231-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-16

Class II · Terminated

Class II FDA medical device recall by GE Inspection Technologies, LP, initiated 2015-12-16, terminated 2016-10-14. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.. Reason: GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X¿ ray System performance standards, 21 C.F.R. ¿ 1020.40(c)(1)(i).

Recalling firm: GE Inspection Technologies, LP
Classification: Class II
Status: Terminated
Initiated: 2015-12-16
Terminated: 2016-10-14
Firm location: Lewistown, PA, United States

Product description

GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

Reason for recall

GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X¿ ray System performance standards, 21 C.F.R. ¿ 1020.40(c)(1)(i)

Data sourced from openFDA. This site is unofficial and independent of the FDA.