| Date Initiated by Firm | October 07, 2005 |
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| Date Posted | October 15, 2005 |
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| Recall Status1 |
Terminated 3 on February 10, 2011 |
| Recall Number | Z-0187-05 |
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| Recall Event ID |
33759 |
| Product Classification |
unknown device name - Product Code ZZZ
|
| Product | CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS);
Product is manufactured by InVision Technologies, Inc., Newark, CA |
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| Code Information |
All units of these models: CTX: 5500, 2500 |
Recalling Firm/
Manufacturer |
Invision Technologies Inc
7151 Gateway Blvd
Newark CA 94560-1012
|
Manufacturer Reason
for Recall | X-ray leakage exceed exposure standard of 0.5 mR/hr. |
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FDA Determined
Cause 2 | Other |
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| 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.
|
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| Quantity in Commerce | 634 inits |
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| Distribution | Distributed nationwide primarily in the airports. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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