Recall Z-2172-2017 ยท GEX Powered Laser Surgical Instrument
Laserex Systems Inc.
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectom
| Date | Jun 6, 2017 (initiated Apr 4, 2017) |
| Status | Terminated |
| Reason | It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient. |
| Root cause | Device Design |
| Action | Ellex Medical shall, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard. 1. Installation of a spacer/collar to prevent the slit lamp from being lowered to the point where the cable can be crushed, 2. Improvement of cable management, 3. The corrections will be conducted at no cost to the purchaser, and 4. The corrective action will be completed by June 30, 2017. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This of |
| Quantity | 83 |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.