CLASS II Device recall · Reported 3 Jan 2018 · FDA Enforcement Report

System Cabinet X-ray system used recalled by L3 Security & Detection

L3 Security & Detection is recalling L3 Security & Detection System Cabinet X-ray system used for security screening of, distributed nationwide in the US. The recall was initiated on 27 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number : Examiner 3DX 6000 cabinet x-ray system
Quantity recalled471

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0270-2018
FDA event ID
78658
Recalling firm
L3 Security & Detection, Woburn, MA
Classification
Class II
Status
Terminated
Recall initiated
27 Oct 2017
FDA classified
22 Dec 2017
Reported
3 Jan 2018
Type
FDA Mandated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

27 Oct 2017Recall initiated by company
22 Dec 2017Classified by FDA+56 days
3 Jan 2018Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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)).

Product as listed by the FDA

L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.

Where it was distributed

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.

Nationwide Virginia

Questions about this recall

Is System Cabinet X-ray system used for security screening of checked airline baggage recalled?

Yes. L3 Security & Detection recalled System Cabinet X-ray system used for security screening of checked airline baggage on 27 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0270-2018.

Why was it recalled?

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)).

Which lots are affected?

Model Number : Examiner 3DX 6000 cabinet x-ray system

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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