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

FDA Device Recall #Z-2777-2017 — Class II — June 28, 2017

Recall Summary

Recall Number Z-2777-2017
Classification Class II — Moderate risk
Date Initiated June 28, 2017
Status Terminated
Voluntary FDA Mandated

Recalling Firm

Firm GE Inspection Technologies, LP
Location Lewistown, PA
Product Type Devices
Quantity 13 units distributed in the US

Product Description

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

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.

Distribution Pattern

US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore

Lot / Code Information

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

Other Recalls from GE Inspection Technologies, LP

Recall # Classification Product Date
Z-2236-2016 Class II GE Inspection Technologies, LP - Phoenix v|tome... Mar 2, 2016
Z-1231-2016 Class II GE Inspection Technologies, LP, Cabinet X-ray s... Dec 16, 2015
Z-1211-2015 Class II GE Inspection Technologies x|tome|x L240 an Cab... Jan 13, 2015
Z-1225-2015 Class II GE Inspection Technologies x|argos 160D system... Jan 13, 2015
Z-2320-2015 Class II GE Optional Laser Centering Device X-ray gener... Nov 10, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.