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
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
- Device type
- Imaging Equipment
Timeline
| 27 Oct 2017 | Recall initiated by company | |
| 22 Dec 2017 | Classified by FDA | +56 days |
| 3 Jan 2018 | Published 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.
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.
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |