FDA Recall
Terminated
CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA
Recall: Z-0187-05
·
Initiated October 7, 2005
Recall
- Recall Number
- Z-0187-05
- Event Number
- 33759
- Firm
- Invision Technologies Inc
- FEI Number
- 3000719027
- Product Code
- ZZZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 7, 2005
- Posted
- October 15, 2005
- Terminated
- February 10, 2011
- Address
- 7151 Gateway Blvd, Newark, CA, 94560-1012
Description
CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA
Reason
X-ray leakage exceed exposure standard of 0.5 mR/hr.
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.
Distribution
Distributed nationwide primarily in the airports.
Quantity
634 inits