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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Omega Medical Imaging, Inc.: Elevating Monitor Suspension Recalled for Monitor Detachment Risk

Agency Publication Date: October 24, 2023
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Summary

Omega Medical Imaging is recalling 52 units of its Elevating Monitor Suspension (Part Number 1000-0085) because a mechanical part can fail and cause the monitor to detach. In one incident, an actuator separated from the pivot mechanism on a lower boom column, causing the monitor to fall until it was caught by a safety cable. This recall affects all units manufactured between October 22, 2012, and July 9, 2019, which were distributed across the United States and Pakistan. If you have this system installed, you should contact Omega Medical Imaging immediately for guidance on inspections or repairs.

Risk

The monitor boom's actuator can separate from the pivot mechanism, which may cause the heavy monitor assembly to fall or become unstable. While a safety cable is designed to restrain the falling monitor, a failure of this system during a medical procedure could result in injury to patients or healthcare staff.

What You Should Do

  1. Identify your equipment by checking for the Omega Medical Imaging Elevating Monitor Suspension, specifically Part Number 1000-0085.
  2. Verify the manufacturing date of your system; this recall applies to all units manufactured between October 22, 2012, and July 9, 2019.
  3. Contact your healthcare facility's engineering or biomedical department to ensure the monitor boom is properly secured and the safety cable is intact.
  4. Contact Omega Medical Imaging at 3400 Saint Johns Pkwy Ste 1020, Sanford, Florida, 32771-6769, or through the contact information provided during the firm's email notification for further instructions regarding the repair or replacement of affected components.
  5. Report any incidents or equipment failures to Omega Medical Imaging and your healthcare provider.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Omega Medical Imaging Elevating Monitor Suspension
Model / REF:
1000-0085
Lot Numbers:
all units manufactured between 10-22-2012 and 07-09-2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93018
Status: Active
Manufacturer: Omega Medical Imaging, Inc.
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 52 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.