Prism Laser 7642 Laser System

Date posted by the FDA

Aug. 29, 2011

Status

Terminated

Filed by

American Stress Technologies, Inc.

Product

Prism Laser 7642 Laser System

Reason

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

Distribution pattern

Nationwide Distribution

Quantity

1

Codes and lots

S/N 7642/2009

Recall started

April 27, 2011

Device type

Analytical Measuring And Detection Laser Product

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

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

Recall number

Z-2600-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2600-2011. The agency record governs; check it and the company before acting.