Z-1122-2007

LaserTrak, Model No. LT80, ASI, Houston, TX 77024

Name: Z-1122-2007 LaserTrak, Model No. LT80, ASI, Houston, TX 77024
Creator: K Tek
Published: 2006-11-03
License: https://open.fda.gov/license/

K Tek / initiated 2006-11-03 / Terminated / root cause: labeling and UDI

FDA source

K Tek began a recall of LaserTrak, Model No. LT80, ASI, Houston, TX 77024 on 2006-11-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1122-2007
Status: Terminated
Initiated: 2006-11-03
Posted: 2007-09-25
Terminated: 2008-12-10
Recalling firm: K Tek
Product: LaserTrak, Model No. LT80, ASI, Houston, TX 77024
Product code: K--DD
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Other
Action: The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.
Quantity in commerce: 139 units
Distribution: Nationwide
Product codes and lots: Model No. LT80

Product code K--DD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)