The Recall Desk

Manufacturer

superDimension, Inc

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2012-07-18

Of the 1 recalls from superDimension, 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.

1–1 of 1

  • HighFDA (Devices)·Z-2001-2012·2012-07-18

    superDimension Systems Software Recall Due to Locatable Guide Malfunction

    superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.

    Product
    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. I
    Category
    Medical Device
    Distribution
    Distributed nationwide