Z-2600-2011

Prism Laser 7642 Laser System

Name: Z-2600-2011 Prism Laser 7642 Laser System
Creator: American Stress Technologies, Inc.
Published: 2011-04-27
License: https://open.fda.gov/license/

American Stress Technologies, Inc. / initiated 2011-04-27 / Terminated / root cause: labeling and UDI

FDA source

American Stress Technologies, Inc. began a recall of Prism Laser 7642 Laser System on 2011-04-27. The reason FDA records is "It was discovered The Prism 7642 was not certified at the time of delivery. The product lacks the required labeling and the product was sold and delivered without the submission of the Initial Product Report. The...". 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-2600-2011
Status: Terminated
Initiated: 2011-04-27
Posted: 2011-08-29
Terminated: 2016-10-13
Recalling firm: American Stress Technologies, Inc.
Product: Prism Laser 7642 Laser System
Product code: REO Analytical Measuring And Detection Laser Product
Reason for recall: It was discovered The Prism 7642 was not certified at the time of delivery. The product lacks the required labeling and the product was sold and delivered without the submission of the Initial Product Report. The product lacks User In formation
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: American Stress Technologies sent a customer notification letter dated April 1, 2011, informing them of the action they have taken to correct this issue. (1) ASTI conducted laser safety tests and checks on May 3,2011 to verify the Prism was compliant with FDA regulations. This was confirmed in a June 17, 2011, electronic mail message. (2) ASTI placed the required labels described in the initial product report on the Prism on May 3, 2011. (3) ASTI delivered updated user manuals to UNO on May 3, 2011, that describe potential laser hazards and the required labeling in the same way as described in the initial product report. (4) ASTI completed the above corrective actions at no cost to UNO as confirmed in a June 20, 2011, electronic mail message. If you have any further questions please call (724) 410-1030
Quantity in commerce: 1
Distribution: Nationwide Distribution
Product codes and lots: S/N 7642/2009

Product code REO

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)