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U.S. Department of Health and Human Services

Class 2 Device Recall Aerolase lasers

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 Class 2 Recall
Aerolase lasers
see related information
Date Posted March 29, 2012
Recall Status1 Open
Recall Number Z-1188-2012
Recall Event ID 61194
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under names including FriendlyLight Er:YAG, LightPod Era, FriendlyLight Nd:YAG, LightPod Neo, LightPod Neo XL, LightPod Neo XT, LightPod Forte, LightPod Allure, and LightPod Nova.
Code Information YAG 1064nm laser, YAG 2940nm laser
Recalling Firm/
Manufacturer
Aerolase
777 Old Saw Mill River Rd
Tarrytown, New York 10591-6717
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Dr. Pavel Efremkin
914-345-8300
Manufacturer Reason
for Recall
It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action Aerolase issued a letter to customers, dated 11/30/2011, identifying the affected product and the reason for the recall. Aerolase is providing, at no charge, the Appendix to the Operating Manual for the LightPod lasers. This Appendix describes the procedure and frequency for checking whether the laser is within calibration, but it is not a procedure for customers to actually calibrate the laser themselves; any attempt to do so by any parties other than a company technician employed by Aerolase would void the warranty. Please contact us any time at 914- 345-8300 with any questions.
Quantity in Commerce 176
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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