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Terminated

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

FDA Recall Z-1231-2016 · Posted None

Recalling FirmGE Inspection Technologies, LP
Recall StatusTerminated
Product CodeRCE
Date Initiated2015-12-16
Date Terminated2016-10-14
Product Quantity55 US Distribution

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)

Firm Action

GE Inspection Technologies Planned Action to bring into Compliance: 1. GE Inspection Technologies will use their updated adhesive procedure to install new brackets to the bottom left and right lead strips in the control door. The new procedure and brackets were developed in November 2013. 2. A second notification of customers with affected systems will be sent within 5 days of approval of this CAP. This notification will describe the repair above and propose that a GE technician visit each site and install the described repair. 3. Repairs will be completed within 120 days after approval of this CAP and will be made free of charge. For further questions, please call (717) 447-1278. ;

Root Cause

Vendor change control

Distribution Pattern

US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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