Recall Z-0270-2018— L3 Security & Detection
Class II · Terminated
Class II FDA medical device recall by L3 Security & Detection, initiated 2017-10-27, terminated 2020-02-10. FDA's recall record names no specific 510(k) clearance for this event. Product: L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.. 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))..
- Recalling firm
- L3 Security & Detection
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-27
- Terminated
- 2020-02-10
- Firm location
- Woburn, MA, United States
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)).
Data sourced from openFDA. This site is unofficial and independent of the FDA.