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

Agency Publication Date: October 24, 2023

Summary

Omega Medical Imaging is recalling 31 units of its Elevating Monitor Suspension Systems (Part Number 1000-0085) because an actuator can separate from the pivot mechanism on the lower monitor boom. If this occurs, the lower boom can detach from the system column, potentially causing the heavy monitor assembly to fall. While a safety cable is installed to restrain the boom if it detaches, the failure of the primary support mechanism creates a hazard in medical environments. These units were manufactured between October 22, 2012, and July 9, 2019.

Risk

The actuator can separate from the pivot mechanism, causing the lower monitor boom to physically detach from the main column. This poses a risk of impact or crush injuries to patients or healthcare staff if the secondary safety cable fails or if the sudden movement of the detached boom strikes a person.

What You Should Do

Identify your equipment by checking for the Omega Medical Imaging Elevating Monitor Suspension System, specifically Part Number 1000-0085.
Verify if your specific unit was manufactured between October 22, 2012, and July 9, 2019, as all units produced in this date range are affected.
Visually inspect the lower monitor boom system column for any signs of loosening or separation at the pivot mechanism.
Contact Omega Medical Imaging, Inc. immediately at their Sanford, Florida location or via the contact information provided in your initial e-mail notification to arrange for inspection or repair.
Report any incidents of detachment or equipment failure to the FDA and the manufacturer to ensure consumer safety tracking.
For additional questions or to report a problem, 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

Other Action

Equipment inspection and potential repair

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

Affected Products

Product: Omega Medical Imaging Elevating Monitor Suspension Systems

Model / REF:

1000-0085

Z-0160-2024

Date Ranges: Manufactured between 10-22-2012 and 07-09-2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93123

Status: Active

Manufacturer: Omega Medical Imaging, Inc.

Sold By: Direct Sales; Authorized Distributors

Manufactured In: United States

Units Affected: 31 units

Distributed To: Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma

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 · 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.

Summary

Risk

What You Should Do

Identify your equipment by checking for the Omega Medical Imaging Elevating Monitor Suspension System, specifically Part Number 1000-0085.

Verify if your specific unit was manufactured between October 22, 2012, and July 9, 2019, as all units produced in this date range are affected.

Visually inspect the lower monitor boom system column for any signs of loosening or separation at the pivot mechanism.

Contact Omega Medical Imaging, Inc. immediately at their Sanford, Florida location or via the contact information provided in your initial e-mail notification to arrange for inspection or repair.

Report any incidents of detachment or equipment failure to the FDA and the manufacturer to ensure consumer safety tracking.

For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.