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U.S. Department of Health and Human Services

Class 2 Device Recall RAPTAR Laser Range Finders

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  Class 2 Device Recall RAPTAR Laser Range Finders see related information
Date Initiated by Firm April 21, 2021
Create Date October 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-0001-2022
Recall Event ID 88735
Product Classification Surveying laser product - Product Code REP
Product RAPTAR Laser Range Finders
Code Information RAPTAR G02 (Wilcox Part #57200G02)
Recalling Firm/
Manufacturer		 Potomac River Group, Corp.
19775 Belmont Executive Plz
Ashburn VA 20147-7600
For Additional Information Contact Frank Frysiek
703-771-3003
Manufacturer Reason
for Recall		 RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Potomac River Group (PRG) sent communications to the purchasers of the affected units that were locked in the eye safe mode and distributed without the keys. PRG expects to offer all affected purchasers at least a refund option. PRG s ability to offer a repair option is contingent upon assistance from Wilcox, which is the only entity PRG is aware of that has the ability to render the units compliant with FDA specifications.
Quantity in Commerce 62 units
Distribution US Nationwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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