Recall Z-1188-2012 ยท GEX Powered Laser Surgical Instrument
Aerolase
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.
| Date | Mar 29, 2012 (initiated Jun 7, 2011) |
| Status | Terminated |
| Reason | It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers. |
| Root cause | 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 | 176 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.