Recall Z-1844-2011 ยท HQF Laser, Ophthalmic
Ellex Medical Pty Ltd
Ellex Solo LT5106-S ophthalmic laser (not sold in USA)
| Date | Apr 12, 2011 (initiated Feb 15, 2011) |
| Status | Terminated |
| Reason | Unintended laser emission while the user was moving the joystick for targeting. |
| Root cause | Process control |
| Action | Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011. |
| Quantity | 193 units |
| Distribution | worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.