RegWardenFDA facility compliance records
Recall

Class II — Omega Medical Imaging, Inc.

Recalling firmOMEGA MEDICAL IMAGING, LLC
Registered facilityOMEGA MEDICAL IMAGING, LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonAn 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.
ProductOmega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Quantity52 units
DistributionWorldwide distribution - US Nationwide and the country of Pakistan.
Initiated2023-02-28
Classified2023-10-24
Recall numberZ-0156-2024
InitiationVoluntary: Firm initiated

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

Cite this record

RegWarden. “Class II recall — Omega Medical Imaging, Inc. (Z-0156-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93018/

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