FDA recall Z-0270-2018

Product

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

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.

Key facts

Status

Terminated

Initiation date

2017-10-27

Report date

2018-01-03

Termination date

2020-02-10

Voluntary/Mandated

FDA Mandated

Location

Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2018