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Terminated

Prism Laser 7642 Laser System

FDA Recall Z-2600-2011 · Posted 2011-08-29

Recalling FirmAmerican Stress Technologies, Inc.
Recall StatusTerminated
Product CodeREO
Date Initiated2011-04-27
Date Terminated2016-10-13
Product Quantity1

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

Firm 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

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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