L3 Security & Detection System Cabinet X-ray system used for security screening of checked airlin...
FDA Device Recall #Z-0270-2018 — Class II — October 27, 2017
Recall Summary
| Recall Number | Z-0270-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 27, 2017 |
| Status | Terminated |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | L3 Security & Detection |
| Location | Woburn, MA |
| Product Type | Devices |
| Quantity | 471 |
Product Description
L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
Reason for Recall
L3 has determined in airport environments, there have been several cases where a small air gap has developed where the entrance or exit tunnels meet up with the main x-ray scanner tunnel. This a gap in x-ray shielding can result in x-ray emissions that exceed the limit in the federal performance standard for cabinet x-ray systems (see 21 CFR ¿ 1020.40(c)(1)).
Distribution Pattern
USA (nationwide) Distribution. Owned and operated by the U.S. Transportation Security Administration. Location of individual products is law enforcement sensitive. TSA HQ is located in Crystal City, Virginia.
Lot / Code Information
Model Number : Examiner 3DX 6000 cabinet x-ray system
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.