Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Summary
The FDA issued a Class II for Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 by Omega Medical Imaging, Inc.. Reason: An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety ca.
Details
Source
Device Recall
External ID
Z-0156-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Lot/Code Info: all units manufactured between 10-22-2012 and 07-09-2019
Quantity Affected: 52 units
Reason for Recall
An 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.
Distribution
Worldwide distribution - US Nationwide and the country of Pakistan.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-28
Company
Sanford, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Omega Medical Imaging, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Omega Medical Imaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Omega Medical Imaging, Inc. have FDA actions?
Omega Medical Imaging, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0156-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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