FDA Medical Device Recalls (openFDA)
Invision Technologies Inc: CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA
- Recall number
- Z-0187-05
- 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
- Status
- Terminated
- Initiated
- 2005-10-07
- Posted
- 2005-10-15
- Terminated
- 2011-02-10
- Reason
- X-ray leakage exceed exposure standard of 0.5 mR/hr.
- 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
- 634 inits
- Distribution
- Distributed nationwide primarily in the airports.
- Lot, serial or model codes
- All units of these models: CTX: 5500, 2500
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ZZZ
- Firm FEI
- 3000719027
- Firm city
- Newark
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28