Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 14, 2017
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.
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.
Laserex Systems Inc. recalled Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is int… - a moderate-severity action.
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is int… was recalled by Laserex Systems Inc. in June 14, 2017. Reason: It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was…. Check the official notice for the remedy. Verify recall #Z-2172-2017 with the FDA Devices before acting.
The recall
Laserex Systems Inc. issued this moderate-severity FDA Devices recall-It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was….
- Moderate
- severity level
- 83 units
- affected scope
- Class II
- classification
- June 14, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2172-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2172-2017) was formally reported on June 14, 2017, with the manufacturer initiating the action on April 4, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Laserex Systems Inc. is listed as the recalling firm, operating out of EDEN PRAIRIE, MN. Federal records list the affected scope as 83.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
83
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2172-2017 |
| Date reported | June 14, 2017 |
| Date initiated | April 4, 2017 |
| Recalling firm | Laserex Systems Inc. |
| Firm location | EDEN PRAIRIE, MN |
| Affected scope | 83 |
| Distribution | US Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2172-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Laserex Systems Inc.. Units affected: 83.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2172-2017.
Where was the recalled product distributed? ▼
Distribution: US Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2172-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 14, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.