Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

FDA Recall #Z-0160-2024 — Class II — September 8, 2023

Recall #Z-0160-2024 Date: September 8, 2023 Classification: Class II Status: Ongoing

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.

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