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Terminated

CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA

FDA Recall Z-0187-05 · Posted 2005-10-15

Recalling FirmInvision Technologies Inc
Recall StatusTerminated
Product CodeZZZ
Date Initiated2005-10-07
Date Terminated2011-02-10
Product Quantity634 inits

Reason for Recall

X-ray leakage exceed exposure standard of 0.5 mR/hr.

Firm Action

On 10/7/05, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the Corrective Action Plan (CAP). The changes will be completed on each CTX 5500/2500 at the next scheduled monthly maintenance visit by InVision Field Service Engineer.

Root Cause

Other

Distribution Pattern

Distributed nationwide primarily in the airports.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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