The Recall Desk

Manufacturer

Laserex Systems Inc.

2 recalls in our database name Laserex Systems Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2017-06-14

Of the 2 recalls from Laserex Systems Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • SevereFDA (Devices)·Z-2172-2017·2017-06-14

    Laserex Systems Recalls Ellex Tango Reflex Laser Ophthalmic Units

    Laserex Systems Inc. is recalling 83 Ellex Tango Reflex laser ophthalmic units because they may emit laser energy without the fire button being pressed.

    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 r
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1270-2016·2016-04-13

    Laserex Systems Recalls Ellex Medical Fixed Eye Safety Filters

    Laserex Systems Inc. is recalling 74 Ellex Medical Fixed Eye Safety Filters due to a design error in the optic adaptor that may compromise eye protection.

    Product
    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
    Category
    Medical Device
    Distribution
    0 states