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U.S. Department of Health and Human Services

Class 2 Device Recall Aimshot HeatSeeker

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  Class 2 Device Recall Aimshot HeatSeeker see related information
Date Initiated by Firm August 17, 2010
Date Posted December 22, 2010
Recall Status1 Terminated 3 on November 09, 2011
Recall Number Z-0507-2011
Recall Event ID 57376
Product Classification Surveying Laser Product - Product Code REP
Product Aimshot HeatSeeker Model HS3500, contains Class IIIb infared laser illuminator.

Amstech Incorporated, Alpharetta, GA 30022.

Targeting, detecting heated areas, searches.
Code Information Model HS3500
Recalling Firm/
Manufacturer		 Amstech Incorporated
340 Dewpoint Lane
Alpharetta GA 30022
For Additional Information Contact Chung Tien aka Citi Cheng
770-840-8039
Manufacturer Reason
for Recall		 Product contains infra red laser, which can pose a potential hazard to users who unknowingly shine the beam into people's eyes.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Firm sent a letter dated August 5, 2010 to customers stating that a recall was being conducted on the AimSHOT HeatSeeker and specified model. The letter stated the reason for the recall and that the firm has redesigned the HeatSeeker and removed the infra red laser feature. The letter also asks customers to check their inventory and return the affected products to the firm. The firm states that they will send customers their new model and pay for the shipping. Questions should be directed towards 770-840-8039.
Quantity in Commerce All units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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.
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