Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Prism Laser 7642

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Prism Laser 7642see related information
Date Initiated by FirmApril 27, 2011
Date PostedAugust 29, 2011
Recall Status1 Terminated 3 on October 13, 2016
Recall NumberZ-2600-2011
Recall Event ID 58804
Product Classification Analytical measuring and detection laser product - Product Code REO
ProductPrism Laser 7642 Laser System
Code Information S/N 7642/2009
Recalling Firm/
Manufacturer		 American Stress Technologies, Inc.
840 Watercrest Way
Cheswick PA 15024
Manufacturer 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
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionAmerican 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 Commerce1
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-