RegWardenFDA facility compliance records
Company

DICOM Grid dba Ambra Health dba Intelerad Holdings USA Ltd

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2016: 1 recalls; 2025: 1 recalls1201620172018201920202021202220232024120252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-11-18
    Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate len…
  • Class IITerminated2016-12-16
    A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “DICOM Grid dba Ambra Health dba Intelerad Holdings USA Ltd — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10034899-dicom-grid-dba-ambra-health-dba-intelera/

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