GE Cabinet X-ray systems
FDA Device Recall #Z-0426-2015 — Class II — November 10, 2014
Recall Summary
| Recall Number | Z-0426-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 10, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Inspection Technologies, LP |
| Location | Lewistown, PA |
| Product Type | Devices |
| Quantity | 11 |
Product Description
GE Cabinet X-ray systems
Reason for Recall
GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
Distribution Pattern
US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
Lot / Code Information
XXL cabinet x-ray systems, serial numbers A586590 and A586780; xlcube compact cabinet x-ray systems, serial numbers A583730, A586430, and A586460; a VTOMEX C450 cabinet x-ray system, serial number VTXO1JOOO2-2245 14; VTOMEX L300 cabinet x-ray systems, serial numbers VTX01lF007-208813, VTX01F007-196312 and VTXO1FOO07-1946 12; and VTOMEX L450 cabinet x-ray systems, serial numbers VTXO1K0001-184711 and PX_10E000-179013.
Other Recalls from GE Inspection Technologies, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2777-2017 | Class II | GE Inspection Technologies Blade|line Industria... | Jun 28, 2017 |
| 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 |
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.