Date Initiated by Firm | June 07, 2011 |
Date Posted | March 29, 2012 |
Recall Status1 |
Terminated 3 on June 29, 2018 |
Recall Number | Z-1188-2012 |
Recall Event ID |
61194 |
Product Classification |
Powered laser surgical instrument - Product Code GEX
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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 NY 10591-6717
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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 |
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 |
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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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