Z-0270-2018 Class II Terminated
FDA device recall Z-0270-2018 was initiated by L3 Security & Detection on October 27, 2017 and is designated Class II. 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 … The recall status is terminated (terminated February 10, 2020). Affected quantity: 471.
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2018
- Initiation Date
- October 27, 2017
- Termination Date
- February 10, 2020
- Voluntary/Mandated
- FDA Mandated
- Product 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.
Code Information
Model Number : Examiner 3DX 6000 cabinet x-ray system