Recall Z-0811-2014 ยท HQF Laser, Ophthalmic
Ziemer Usa Inc
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of
| Date | Jan 23, 2014 (initiated Apr 16, 2013) |
| Status | Terminated |
| Reason | A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off. |
| Root cause | Component design/selection |
| Action | A recall notification letter dated April 16, 2013 was mailed to direct accounts. The letter notified the direct accounts of the problem and advised them that a technician would be arriving at their facility during the week of June 2, 2013 to replace the defective controller board. The technician will also perform preventative maintenance on the device at the same time. Direct accounts are advised to contact Ziemer USA, Inc. at 618-462-9301 if they have any questions about this issue. |
| Quantity | 5 units |
| Distribution | Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112154 | FEMTO LDV Sie Ag,Surgical Instument Engineering, Mar 16, 2012 |