Z-2777-2017Class II

GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

Name: Z-2777-2017 GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
Creator: GE Inspection Technologies, LP
Published: 2017-06-28
License: https://open.fda.gov/license/

GE Inspection Technologies, LP / initiated 2017-06-28 / Terminated

FDA source

GE Inspection Technologies, LP began a recall of GE Inspection Technologies Blade|line Industrial Cabinet X-ray system on 2017-06-28. FDA classified it as Class II and gives the reason as "GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR 1020.40(c)(1)(i))...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2777-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-28
Posted: 2017-08-01
Terminated: 2020-02-06
Recalling firm: GE Inspection Technologies, LP
Product: GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
Product code: RCE Cabinet X-Ray, Industrial
Reason for recall: GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Inspection Technologies will bring the defect into compliance: 1. Four panels of sheet metal/lead/sheet metal construction (6 mm lead thickness) will be permanently mounted using an industrial epoxy to the inside floor of the cabinet to prevent emissions from exceeding the limit in the performance standard. A radiation emission measurement will be made following the repairs of each system to assure the issue was corrected. 2. GE will notify affected customers within 5 days of GEs receipt of this approval letter. 3. The notification will recommend that customers allow GE to visit the site and install the new shielding within 120 days following GEs receipt of this letter. 4.The text of the notification to customers will include the required statement that confirms that GE will, without charge, bring the affected cabinet x-ray systems into compliance with the performance standard. For further questions, please call (717) 447-1278.
Quantity in commerce: 13 units distributed in the US
Distribution: US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
Product codes and lots: Serial No. TM 201317 TM 201312 TM 201323 TM 201331 TM 201401 TM 201329 TM 201404 TM 201413 TM 201414 TM 201415 TM 201424 TM 201425 158017R1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2777-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2777-2017	Class II	Terminated	FDA Mandated	2017-08-09	2017-08-01

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)