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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
