RegWardenFDA facility compliance records
Company

OMEGA MEDICAL IMAGING, LLC

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2017: 1 recalls; 2023: 2 recalls12016120172018201920202021202222023202420252026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-09-08
    An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.
  • Class IIOngoing2023-02-28
    An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
  • Class IITerminated2017-03-23
    Elevating Monitor Suspension column dropping and will not rise back up.
  • Class IITerminated2016-06-21
    Elevating Monitor Suspension separated from the lifting column bracket

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. “OMEGA MEDICAL IMAGING, LLC — 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-9000656-omega-medical-imaging-llc/

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