Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
FDA Recall #Z-0160-2024 — Class II — September 8, 2023
Product Description
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Reason for Recall
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.
Recalling Firm
Omega Medical Imaging, Inc. — Sanford, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
31 units
Distribution
Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
Code Information
all units manufactured between 10-22-2012 and 07-09-2019
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.