RegWardenFDA facility compliance records
Facility

DICOM Grid (dba Ambra Health)

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

Activity by year

FDA actions on record by year2016: 1 recalls; 2019: 1 inspections; 2022: 1 inspections; 2025: 1 recalls120162017201812019202020211202220232024120252026
  • Recalls (2)
  • Inspections (2)

Devices registered here (1)

  • System, Digital Image Communications, Radiological
    Product code LMD (opens in a new tab) · Class I · Radiology · 21 CFR 892.2020

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.

FDA inspections (2)

  • NAI2022-07-27
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2019-09-25
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DICOM Grid (dba Ambra Health) (FEI 3008776294) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008776294-dicom-grid-dba-ambra-health/

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