The Recall Desk

Manufacturer

Sedecal USA, Inc.

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2016-06-15

Of the 1 recalls from Sedecal USA, 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-1691-2016·2016-06-15

    Sedecal Mobile X-ray System Recalled for Software Defect

    Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.

    Product
    Sedecal SA Mobile Diagnost w DR x-ray system
    Category
    Medical Device
    Distribution
    30 states