Z-2172-2017Class II

Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for...

Name: Z-2172-2017 Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for...
Creator: Laserex Systems Inc.
Published: 2017-04-04
License: https://open.fda.gov/license/

Ellex Medical Pty Ltd / initiated 2017-04-04 / Terminated / root cause: design

FDA source

Laserex Systems Inc. began a recall of 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... on 2017-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2172-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-04
Posted: 2017-06-06
Terminated: 2017-07-31
Recalling firm: Ellex Medical Pty Ltd
Product: 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 membranectomy.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: 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 tag: design
FDA 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 office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (800) 824-7444.
Quantity in commerce: 83
Distribution: US Distribution
Product codes and lots: Serial No: TR 0010, TR 0095

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2172-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2172-2017	Class II	Terminated	FDA Mandated	2017-06-14	2017-06-06

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)