Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0187-05

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

Invision Technologies Inc / initiated 2005-10-07 / Terminated

Invision Technologies Inc began a recall of CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA on . The reason FDA records is "X-ray leakage exceed exposure standard of 0.5 mR/hr". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0187-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invision Technologies Inc
Product
CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA
Product code
ZZZ
Reason for recall
X-ray leakage exceed exposure standard of 0.5 mR/hr.
FDA root cause
Other
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.
Quantity in commerce
634 inits
Distribution
Distributed nationwide primarily in the airports.
Product codes and lots
All units of these models: CTX: 5500, 2500