Z-1231-2016Class II

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

Name: Z-1231-2016 GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control
Creator: GE Inspection Technologies, LP
Published: 2015-12-16
License: https://open.fda.gov/license/

GE Inspection Technologies, LP / initiated 2015-12-16 / Terminated / root cause: supplier

FDA source

GE Inspection Technologies, LP began a recall of GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control on 2015-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1231-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-16
Posted: 2016-04-01
Terminated: 2016-10-14
Recalling firm: GE Inspection Technologies, LP
Product: GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Product code: RCE Cabinet X-Ray, Industrial
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)
Root cause tag: supplier
FDA root cause: Vendor change control
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. ;
Quantity in commerce: 55 US Distribution
Distribution: 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.
Product codes and lots: phoenix micrornelx and nanomelx cabinet x-ray systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1231-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1231-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-01

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)