FDA Medical Device Recalls (openFDA)
K Tek: LaserTrak, Model No. LT80, ASI, Houston, TX 77024
- Recall number
- Z-1122-2007
- Recalling firm
- K Tek
- Product
- LaserTrak, Model No. LT80, ASI, Houston, TX 77024
- Status
- Terminated
- Initiated
- 2006-11-03
- Posted
- 2007-09-25
- Terminated
- 2008-12-10
- Reason
- Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports)
- Root cause
- Other
- Action
- The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.
- Quantity
- 139 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Model No. LT80
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- K--DD
- Firm FEI
- 3003115967
- Firm city
- Galvez
- Firm state
- LA
- 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