Medical device recalls Moderate risk

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

Recall date
October 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0270-2018
FDA classification
Class II
Brand / firm
L3 Security & Detection
Sold / 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.

Why it was 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)).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever L3 Security & Detection has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: L3 Security & Detection