The Recall Desk

Manufacturer

Topcon Medical Laser Systems, Inc

2 recalls in our database name Topcon Medical Laser Systems, Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2016-08-17

Of the 2 recalls from Topcon Medical Laser 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 0 (0%) 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

  • ModerateFDA (Devices)·Z-2405-2016·2016-08-17

    Topcon Recalls PASCAL Synthesis Ophthalmic Laser Systems Due to Titration Anomaly

    Topcon Medical Laser Systems is recalling 205 PASCAL Synthesis ophthalmic laser systems worldwide due to a software anomaly affecting the titration process when specific functions are used.

    Product
    Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2013·2013-07-31

    Topcon PASCAL Laser Recall Due to Power Mismatch Risk

    Topcon Medical Laser Systems is recalling PASCAL and PASCAL Streamline lasers because a software function may cause power output mismatches, leading to over or under treatment.

    Product
    PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
    Category
    Medical Device
    Distribution
    0 states