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Recall Observatory FDA recall evidence

Device product

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

Z-0270-2018

October 27, 2017

Class II

Product summary

Firm
L3 Security & Detection
Event
Event 78658
Status
Terminated
Classification
Class II
Quantity
471
Official record key
device-enforcement:Z-0270-2018

Official wording

Reason: 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)).

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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)).