The Recall Desk

Manufacturer

Stereotaxis Inc

1 recall in our database name Stereotaxis Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2020-11-18

Of the 1 recalls from Stereotaxis 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 (100%) 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.

1–1 of 1

  • SevereFDA (Devices)·Z-0430-2021·2020-11-18

    Stereotaxis Niobe ES System Recalled for Potential Fire Hazard

    Stereotaxis Inc is recalling 121 Niobe ES Systems due to a potential fire risk in the internal computer cabinet.

    Product
    Niobe ES System, Models 001-006000-1 and 001-006100-1
    Category
    Medical Device
    Distribution
    0 states